xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022640</url>
    </required_header>
    <id_info>
      <org_study_id>AR200111</org_study_id>
      <nct_id>NCT06022640</nct_id>
    </id_info>
    <brief_title>Educational and Supportive Care to Depressed Infertile Females</brief_title>
    <official_title>The Assessment of Educational and Supportive Care to the Depressed Infertile Females Undergo In Vitro Fertilization Procedure by Clinical Pharmacist: Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Rasheed University College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Rasheed University College</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Infertility affects married adults, and In Vitro Fertilization (IVF) is an Assisted&#xD;
        Reproductive Technology (ART) that can be treated. Women undergoing IVF are more likely to&#xD;
        experience depression. There is a need to reduce depression by supporting and advising&#xD;
        sufferers. The aim of this study is to evaluate pharmacist counseling's impact on pregnancy&#xD;
        rates in depressed infertile females during IVF treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Infertility affects 10-15% of couples, both men and women, and can cause anxiety, worry,&#xD;
        grief, and disappointment. It is a major life experience that can affect all aspects of a&#xD;
        couple's life. Preconception counseling is a necessary prerequisite for infertility&#xD;
        treatment, as it evaluates the medical, social, genetic, environmental, and occupational&#xD;
        factors that influence fertility and pregnancy health. Depression is a common issue among&#xD;
        infertile females, and pharmacists play a crucial role in the care of depressed patients.&#xD;
  &#xD;
        The etiology of female infertility is unknown, but ovulatory disorders, endometriosis, pelvic&#xD;
        adhesions, tubal blockage, other tubal abnormalities, and hyperprolactinemia account for 81%&#xD;
        of all cases. Age has a negative impact on fertility, and the prevalence of age-related&#xD;
        infertility rises as reproductive years decrease. Treatment for infertility aims to resolve&#xD;
        treatable causes and overcome intractable ones. General management principles for infertile&#xD;
        couples include determining the cause and treatment, suggesting changes in behavior that&#xD;
        increase fertility, stopping smoking, and limiting exposure to harmful substances.&#xD;
  &#xD;
        Assisted reproductive technology (ART) is used to treat infertility, which involves fertility&#xD;
        therapies involving both eggs and sperm. In vitro fertilization (IVF) is widely recognized as&#xD;
        the most effective method of ART. IVF is one of the most successful therapies for&#xD;
        infertility, but it sometimes requires multiple attempts at oocyte picking and embryo&#xD;
        transfer. It is effective in treating undiagnosed infertility, obstructed or broken fallopian&#xD;
        tubes, genetic disorders, women with uterine fibroids, ovulation problems, or early ovarian&#xD;
        failure, and women who have had their ovaries surgically removed.&#xD;
  &#xD;
        The IVF cycle involves ovarian stimulation, which involves fertility drugs to stimulate egg&#xD;
        production and regulate ovulation. Examples of ovarian stimulation regimens include&#xD;
        leuprolide acetate, also known as Lupron, which is used in conjunction with birth control&#xD;
        pills for the first week. Anti-estrogens like clomiphene citrate, also known as Clomid, are&#xD;
        used to manage anovulation by selectively modulating estrogen receptor activity.&#xD;
        Follicle-stimulating hormone (FSH) is a medication that stimulates the ovaries, potentially&#xD;
        serving as an alternative therapeutic option for women with anovulation who have undergone&#xD;
        unsuccessful cycles of anti-estrogens. Human chorionic gonadotropin injections (HCG) are&#xD;
        commonly used to induce ultimate maturation, stimulating ovulation when there is at least one&#xD;
        fully developed ovarian follicle. The American Society for Reproductive Medicine advises the&#xD;
        transfer of a specific quantity of embryos, whether they are in a fresh or frozen state.&#xD;
  &#xD;
        Emotional changes in IVF patients are common, with anxiety and depression being more common&#xD;
        in infertility patients with psychiatric illness, miscarriage, a longer infertility timeline,&#xD;
        and a definitive medical diagnosis. Stress levels increase as therapy becomes more intensive&#xD;
        and lasts longer, making IVF patients more stressed than women at the beginning of their&#xD;
        infertility examination.&#xD;
  &#xD;
        Infertility and its medications can cause emotional distress for patients, especially those&#xD;
        who have tried multiple IVF cycles without success. Patients may lack familiarity with&#xD;
        gonadotropin self-injection, hormone supplements, and other necessary treatments for&#xD;
        ovulation induction cycles. Studies show that depression lowers IVF pregnancy rates, but the&#xD;
        impact on emotional distress is uncertain.&#xD;
  &#xD;
        Grief responses are frequently observed among couples experiencing infertility, but typical&#xD;
        grief responses can progress into pathological grief, resulting in notable melancholic&#xD;
        symptoms. In women, the prevalence of infertility depression ranges from 10-25%, with women&#xD;
        experiencing major depression at rates two to three times higher than men. Depression can&#xD;
        negatively impact treatment, follow-up, and confidence for the future, as well as the&#xD;
        intensity and durability of the affected couple's relationship. The Centre for&#xD;
        Epidemiological Studies Depression Scale (CES-D) measures depression symptoms across various&#xD;
        demographics, including race, ethnicity, gender, and age.&#xD;
  &#xD;
        The Fertility Quality of Life Tool (FertiQoL) is an internationally validated instrument&#xD;
        designed to measure the quality of life in people experiencing infertility. The FertiQoL&#xD;
        questionnaire is beneficial for infertile patients due to its strong construct validity and&#xD;
        reliable psychometric properties.&#xD;
  &#xD;
        Pharmacists play a significant role in education and supportive care for depressed patients,&#xD;
        providing advice, recommendations, and counseling about medications, monitoring patients for&#xD;
        drug-related problems, and assessing patient adherence. The modern pharmacist's&#xD;
        responsibilities include pharmaceutical care principles, transforming them from a traditional&#xD;
        medication seller into a critical member of the healthcare team. The goal of these&#xD;
        patient-centered interventions is to improve therapeutic outcomes by recognizing, preventing,&#xD;
        and treating drug-related problems, encouraging the correct use of medication, and promoting&#xD;
        and educating about general health.&#xD;
  &#xD;
        Pharmaceutical care is a systematic, complete approach that requires pharmacists to work with&#xD;
        the healthcare team to detect and treat drug-related difficulties and safeguard patients from&#xD;
        medicine-related damage. The idea of care focuses on developing the pharmacist-patient&#xD;
        connection and adding value to the therapeutic outcome by actively participating in the&#xD;
        treatment method.&#xD;
  &#xD;
        Evidence-based medicine (EBM) is a practice that combines the results of recent scientific&#xD;
        studies with the input of clinicians and patients. The shift in pharmacy practice from&#xD;
        perception to evidence-based practice is crucial for optimal pharmacological treatment. The&#xD;
        Institute of Medicine aims to achieve 90% of healthcare decisions backed by accurate, latest&#xD;
        clinical information by 2020.&#xD;
  &#xD;
        Collaborative counseling has been shown to reduce stress levels in infertile women receiving&#xD;
        IVF by 3.6 times compared to the control group. Psychotherapy is an appealing choice in terms&#xD;
        of treatment, as it has been shown to increase patients' chances of becoming pregnant.&#xD;
  &#xD;
        In most countries, psychological counseling or interpersonal therapy and behavioral&#xD;
        activation are the first-line treatments for depression.&#xD;
  &#xD;
        These studies have shown that infertile women who want to undergo IVF may fail and not get&#xD;
        pregnant due to the patient's depression condition prior to the operation.&#xD;
  &#xD;
        As a result, health education and awareness must be undertaken, and a satisfactory condition&#xD;
        must be provided prior to the operation, with a focus on women because they are more&#xD;
        susceptible to this depression than men.&#xD;
  &#xD;
        The key issue is depression in infertile women, which has an impact on the pregnancy rate&#xD;
        outcome. There is a need to reduce depression by supporting and advising sufferers.&#xD;
  &#xD;
        Aim of study This study examines the effect of depression on the pregnancy rate of infertile&#xD;
        ladies during IVF procedures and the use of counseling and supporting care by pharmacist to&#xD;
        evaluate outcomes of IVF cycles, as measured by clinical pregnancy rates recorded after the&#xD;
        intervention. The secondary outcome: assessment of both groups completed the CES-D scale and&#xD;
        FertiQoL during the start-time and end-time of the IVF procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2022</completion_date>
    <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pregnancy rate</measure>
      <time_frame>Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.</time_frame>
      <description>The outcome of IVF cycles, as measured by clinical pregnancy rates, was recorded after the intervention</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fertility Quality of Life.</measure>
      <time_frame>Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.</time_frame>
      <description>The assessment of Fertility Quality of Life by: FertiQoL during the start and end times of IVF procedure. The scaled scores range is 0 to 100. Higher scores mean higher quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression status</measure>
      <time_frame>Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.</time_frame>
      <description>The assessment of depression will be measured by the Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">150</enrollment>
    <condition>Infertility, Female</condition>
    <condition>Depression</condition>
    <condition>IVF</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group included 75 infertile married ladies attending the hospital for the same purpose and managed in the traditional protocol followed by the hospital system. The study assessed the fertility quality of life and depression status of the patients at the beginning and end of the IVF cycle. All patients received frozen embryo transfers (fertilized eggs), not fresh embryos.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational and supportive care</intervention_name>
      <description>The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an educative and supporting program specifically developed by a clinical pharmacist. The intervention group was provided with assistance via a series of five visits, which included an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and negative effects, as well as visits dedicated to giving emotional support. Additionally, a follow-up visit was conducted after the egg collecting process and embryo transfer.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be an infertile lady who spent at least one year after marriage failing to get&#xD;
               pregnant and who should then undergo the IVF cycle.&#xD;
  &#xD;
            -  To be within the reproductive age (18-45 years old); the success rates of IVF tend to&#xD;
               decline with increasing age[4].&#xD;
  &#xD;
            -  To have the ability to read and understand.&#xD;
  &#xD;
            -  Have depression&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with previous failure of I.V.F. procedure.&#xD;
  &#xD;
            -  Very obese (BMI &gt; 40)[37].&#xD;
  &#xD;
            -  Patient with psychiatric problems (psychiatric hospital admission, addiction,&#xD;
               neurological or other progressive disease, and psychiatric drug use).&#xD;
  &#xD;
            -  A patient who has a situation that prevents communication (language and hearing&#xD;
               problems).&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>To be an infertile lady</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abeer A Rashid, FIBMS</last_name>
      <role>Study Director</role>
      <affiliation>Al-Mustansiriyah University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>College of Pharmacy, Mustansiriyah University</name>
        <address>
          <city>Baghdad</city>
          <zip>10011</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <reference>
      <citation>Maleki-Saghooni N, Amirian M, Sadeghi R, Latifnejad Roudsari R. Effectiveness of infertility counseling on pregnancy rate in infertile patients undergoing assisted reproductive technologies: A systematic review and meta-analysis. Int J Reprod Biomed. 2017 Jul;15(7):391-402.</citation>
      <PMID>29177241</PMID>
    </reference>
    <reference>
      <citation>Al-Homaidan HT. Depression among Women with Primary Infertility attending an Infertility Clinic in Riyadh, Kingdom of Saudi Arabia: Rate, Severity, and Contributing Factors. Int J Health Sci (Qassim). 2011 Jul;5(2):108-15.</citation>
      <PMID>23267288</PMID>
    </reference>
    <reference>
      <citation>Nkansah N, Mostovetsky O, Yu C, Chheng T, Beney J, Bond CM, Bero L. Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD000336. doi: 10.1002/14651858.CD000336.pub2.</citation>
      <PMID>20614422</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Education</keyword>
    <keyword>Supportive care</keyword>
    <keyword>Pharmacist</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Infertility, Female</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022640
  org study id: AR200111
  nct id: NCT06022640
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Infertility affects married adults, and In Vitro Fertilization (IVF) is an Assisted
        Reproductive Technology (ART) that can be treated. Women undergoing IVF are more likely to
        experience depression. There is a need to reduce depression by supporting and advising
        sufferers. The aim of this study is to evaluate pharmacist counseling's impact on pregnancy
        rates in depressed infertile females during IVF treatment.
  Infertility affects 10-15% of couples, both men and women, and can cause anxiety, worry,
        grief, and disappointment. It is a major life experience that can affect all aspects of a
        couple's life. Preconception counseling is a necessary prerequisite for infertility
        treatment, as it evaluates the medical, social, genetic, environmental, and occupational
        factors that influence fertility and pregnancy health. Depression is a common issue among
        infertile females, and pharmacists play a crucial role in the care of depressed patients.
  
        The etiology of female infertility is unknown, but ovulatory disorders, endometriosis, pelvic
        adhesions, tubal blockage, other tubal abnormalities, and hyperprolactinemia account for 81%
        of all cases. Age has a negative impact on fertility, and the prevalence of age-related
        infertility rises as reproductive years decrease. Treatment for infertility aims to resolve
        treatable causes and overcome intractable ones. General management principles for infertile
        couples include determining the cause and treatment, suggesting changes in behavior that
        increase fertility, stopping smoking, and limiting exposure to harmful substances.
  
        Assisted reproductive technology (ART) is used to treat infertility, which involves fertility
        therapies involving both eggs and sperm. In vitro fertilization (IVF) is widely recognized as
        the most effective method of ART. IVF is one of the most successful therapies for
        infertility, but it sometimes requires multiple attempts at oocyte picking and embryo
        transfer. It is effective in treating undiagnosed infertility, obstructed or broken fallopian
        tubes, genetic disorders, women with uterine fibroids, ovulation problems, or early ovarian
        failure, and women who have had their ovaries surgically removed.
  
        The IVF cycle involves ovarian stimulation, which involves fertility drugs to stimulate egg
        production and regulate ovulation. Examples of ovarian stimulation regimens include
        leuprolide acetate, also known as Lupron, which is used in conjunction with birth control
        pills for the first week. Anti-estrogens like clomiphene citrate, also known as Clomid, are
        used to manage anovulation by selectively modulating estrogen receptor activity.
        Follicle-stimulating hormone (FSH) is a medication that stimulates the ovaries, potentially
        serving as an alternative therapeutic option for women with anovulation who have undergone
        unsuccessful cycles of anti-estrogens. Human chorionic gonadotropin injections (HCG) are
        commonly used to induce ultimate maturation, stimulating ovulation when there is at least one
        fully developed ovarian follicle. The American Society for Reproductive Medicine advises the
        transfer of a specific quantity of embryos, whether they are in a fresh or frozen state.
  
        Emotional changes in IVF patients are common, with anxiety and depression being more common
        in infertility patients with psychiatric illness, miscarriage, a longer infertility timeline,
        and a definitive medical diagnosis. Stress levels increase as therapy becomes more intensive
        and lasts longer, making IVF patients more stressed than women at the beginning of their
        infertility examination.
  
        Infertility and its medications can cause emotional distress for patients, especially those
        who have tried multiple IVF cycles without success. Patients may lack familiarity with
        gonadotropin self-injection, hormone supplements, and other necessary treatments for
        ovulation induction cycles. Studies show that depression lowers IVF pregnancy rates, but the
        impact on emotional distress is uncertain.
  
        Grief responses are frequently observed among couples experiencing infertility, but typical
        grief responses can progress into pathological grief, resulting in notable melancholic
        symptoms. In women, the prevalence of infertility depression ranges from 10-25%, with women
        experiencing major depression at rates two to three times higher than men. Depression can
        negatively impact treatment, follow-up, and confidence for the future, as well as the
        intensity and durability of the affected couple's relationship. The Centre for
        Epidemiological Studies Depression Scale (CES-D) measures depression symptoms across various
        demographics, including race, ethnicity, gender, and age.
  
        The Fertility Quality of Life Tool (FertiQoL) is an internationally validated instrument
        designed to measure the quality of life in people experiencing infertility. The FertiQoL
        questionnaire is beneficial for infertile patients due to its strong construct validity and
        reliable psychometric properties.
  
        Pharmacists play a significant role in education and supportive care for depressed patients,
        providing advice, recommendations, and counseling about medications, monitoring patients for
        drug-related problems, and assessing patient adherence. The modern pharmacist's
        responsibilities include pharmaceutical care principles, transforming them from a traditional
        medication seller into a critical member of the healthcare team. The goal of these
        patient-centered interventions is to improve therapeutic outcomes by recognizing, preventing,
        and treating drug-related problems, encouraging the correct use of medication, and promoting
        and educating about general health.
  
        Pharmaceutical care is a systematic, complete approach that requires pharmacists to work with
        the healthcare team to detect and treat drug-related difficulties and safeguard patients from
        medicine-related damage. The idea of care focuses on developing the pharmacist-patient
        connection and adding value to the therapeutic outcome by actively participating in the
        treatment method.
  
        Evidence-based medicine (EBM) is a practice that combines the results of recent scientific
        studies with the input of clinicians and patients. The shift in pharmacy practice from
        perception to evidence-based practice is crucial for optimal pharmacological treatment. The
        Institute of Medicine aims to achieve 90% of healthcare decisions backed by accurate, latest
        clinical information by 2020.
  
        Collaborative counseling has been shown to reduce stress levels in infertile women receiving
        IVF by 3.6 times compared to the control group. Psychotherapy is an appealing choice in terms
        of treatment, as it has been shown to increase patients' chances of becoming pregnant.
  
        In most countries, psychological counseling or interpersonal therapy and behavioral
        activation are the first-line treatments for depression.
  
        These studies have shown that infertile women who want to undergo IVF may fail and not get
        pregnant due to the patient's depression condition prior to the operation.
  
        As a result, health education and awareness must be undertaken, and a satisfactory condition
        must be provided prior to the operation, with a focus on women because they are more
        susceptible to this depression than men.
  
        The key issue is depression in infertile women, which has an impact on the pregnancy rate
        outcome. There is a need to reduce depression by supporting and advising sufferers.
  
        Aim of study This study examines the effect of depression on the pregnancy rate of infertile
        ladies during IVF procedures and the use of counseling and supporting care by pharmacist to
        evaluate outcomes of IVF cycles, as measured by clinical pregnancy rates recorded after the
        intervention. The secondary outcome: assessment of both groups completed the CES-D scale and
        FertiQoL during the start-time and end-time of the IVF procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pregnancy rate
  time frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.
  description: The outcome of IVF cycles, as measured by clinical pregnancy rates, was recorded after the intervention
  measure: Fertility Quality of Life.
  time frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.
  description: The assessment of Fertility Quality of Life by: FertiQoL during the start and end times of IVF procedure. The scaled scores range is 0 to 100. Higher scores mean higher quality of life
  measure: Depression status
  time frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.
  description: The assessment of depression will be measured by the Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology
  arm group label: Group 1
  arm group type: Experimental
  description: The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.
  arm group label: Group 2
  arm group type: No Intervention
  description: The control group included 75 infertile married ladies attending the hospital for the same purpose and managed in the traditional protocol followed by the hospital system. The study assessed the fertility quality of life and depression status of the patients at the beginning and end of the IVF cycle. All patients received frozen embryo transfers (fertilized eggs), not fresh embryos.
  intervention type: Behavioral
  intervention name: Educational and supportive care
  description: The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an educative and supporting program specifically developed by a clinical pharmacist. The intervention group was provided with assistance via a series of five visits, which included an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and negative effects, as well as visits dedicated to giving emotional support. Additionally, a follow-up visit was conducted after the egg collecting process and embryo transfer.
  arm group label: Group 1
  criteria: 
  gender: Female
  gender based: Yes
  gender description: To be an infertile lady
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Abeer A Rashid, FIBMS
  role: Study Director
  affiliation: Al-Mustansiriyah University
  facility: 
  country: Iraq
  citation: Maleki-Saghooni N, Amirian M, Sadeghi R, Latifnejad Roudsari R. Effectiveness of infertility counseling on pregnancy rate in infertile patients undergoing assisted reproductive technologies: A systematic review and meta-analysis. Int J Reprod Biomed. 2017 Jul;15(7):391-402.
  PMID: 29177241
  citation: Al-Homaidan HT. Depression among Women with Primary Infertility attending an Infertility Clinic in Riyadh, Kingdom of Saudi Arabia: Rate, Severity, and Contributing Factors. Int J Health Sci (Qassim). 2011 Jul;5(2):108-15.
  PMID: 23267288
  citation: Nkansah N, Mostovetsky O, Yu C, Chheng T, Beney J, Bond CM, Bero L. Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD000336. doi: 10.1002/14651858.CD000336.pub2.
  PMID: 20614422
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Infertility, Female