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/NCT05972902</url>
    </required_header>
    <id_info>
      <org_study_id>Dydrogesterone IVF</org_study_id>
      <nct_id>NCT05972902</nct_id>
    </id_info>
    <brief_title>Dydrogesterone, Cetrorelix Acetate and Triptorelin in Intra Cytoplasmic Sperm Injection Outcomes</brief_title>
    <official_title>Comparison Between Effects of Dydrogesterone, Cetrorelix Acetate and Triptorelin on Intra Cytoplasmic Sperm Injection Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</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>
        To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention&#xD;
        of premature LH surge and quality of retrieved oocytes and embryos in women undergoing&#xD;
        intra-cytoplasmic sperm injection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design:&#xD;
  &#xD;
        A randomized clinical trial (RCT).&#xD;
  &#xD;
        Study Site:&#xD;
  &#xD;
        The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques&#xD;
        center. The study population includes all infertile women undergoing IVF at Beni-Suef&#xD;
        University ART center will be included. Women will be recruited for enrollment when they come&#xD;
        to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to&#xD;
        participate in the study after been evaluated to ensure fulfilling inclusion and exclusion&#xD;
        criteria.&#xD;
  &#xD;
        Study Sample:&#xD;
  &#xD;
        The study consisted of 387 women which will be randomized into 3 groups. Women will be&#xD;
        enrolled in the study after giving written informed consent. Group (A): 129 Women will start&#xD;
        Dydrogesterone group. Group (B): 129 Women will undergo Agonist protocol group. Group (c):&#xD;
        129 Women will undergo Antagonist protocol group.&#xD;
  &#xD;
        Study Procedure:&#xD;
  &#xD;
        Full history taking. Systematic clinical examination to assess the general condition, body&#xD;
        mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2&#xD;
        to 3 of menstruation. Routine labs as CBC, liver &amp; kidney functions to exclude general&#xD;
        disease as a contraindication for induction or pregnancy. Blood sample obtained for&#xD;
        assessment of basal serum levels of FSH, LH, PRL, AMH and E2 on day 3 of the cycle.&#xD;
  &#xD;
        Ovarian Stimulation:&#xD;
  &#xD;
        #Treatment protocols: The patients begins injections of recombinant FSH (rFSH, Gonal-F;&#xD;
        Merck- Serono, Italy) or human menopausal gonadotropin (hp-hMG, Menopur; Ferring&#xD;
        Pharmaceuticals, Geneva,Switzerland) since day 2-3 of menstruation, with daily dose of&#xD;
        150-450 IU adjusted according to individual conditions on the basis of the antral follicle&#xD;
        count (AFC), age of the woman, body mass index (BMI), and previous ovarian response,&#xD;
        according to the standard operating procedures of the center.&#xD;
  &#xD;
        For pituitary suppression, the patients received:&#xD;
  &#xD;
          -  Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since&#xD;
             day 2-3.&#xD;
  &#xD;
          -  GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously&#xD;
             since the dominant follicles reached the diameter of 12-14 mm till trigger day.&#xD;
  &#xD;
          -  GnRH agonist (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of&#xD;
             the cycle prior to stimulation. The serum LH, estradiol and progesterone levels as well&#xD;
             as number and size of follicles will be monitored every 1 to 2 days, starting from&#xD;
             stimulation day 5 until the day of hCG injection. The daily dose of rFSH will be&#xD;
             adjusted according to patient' s ovarian response, based on serum estradiol levels and&#xD;
             the number and size of ovarian follicles as measured by transvaginal ultrasonography.&#xD;
  &#xD;
        Triggering and Ovum pick uptake:&#xD;
  &#xD;
        Triptorelin (0.2 mg; Decapeptyl, Ferring Pharmaceuticals, the Netherlands) or human chorionic&#xD;
        gonadotropin (10000 IU; Choriomon) or Ovitrel 250 mg (Merck Serono, Italy) are given to&#xD;
        trigger final maturation of the oocytes. Oocyte retrieval was performed approximately 36&#xD;
        hours later.&#xD;
  &#xD;
        Fresh and Frozen Embryo Transfer:&#xD;
  &#xD;
        A maximum of 2 embryos will be transferred on day 3 after retrieval under transabdominal&#xD;
        ultrasound guidance. Day 3 -5 embryos in the antagonist group and all the viable embryos or&#xD;
        blastocysts in the duphaston group are cryopreserved using vitrification.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>Phase 3</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of oocytes retrieved.</measure>
      <time_frame>1cycle (1 month)</time_frame>
      <description>number of oocytes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>maturity of oocytes retrieved.</measure>
      <time_frame>1 cycle (1month)</time_frame>
      <description>either M2 or M1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of stimulation</measure>
      <time_frame>1 ICSI cycle (1 month)</time_frame>
      <description>days till trigger</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">387</enrollment>
    <condition>IVF</condition>
    <arm_group>
      <arm_group_label>Dydrogesterone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GnRH antagonist</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GnRH agonist</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dydrogesterone</intervention_name>
      <description>Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone</description>
      <arm_group_label>Dydrogesterone</arm_group_label>
      <other_name>Duphaston</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cetrorelix acetate</intervention_name>
      <description>GnRH antagonist</description>
      <arm_group_label>GnRH antagonist</arm_group_label>
      <other_name>cetrotide</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Triptorelin</intervention_name>
      <description>GnRH agonist</description>
      <arm_group_label>GnRH agonist</arm_group_label>
      <other_name>Decapeptyl, sc 0.1 mg/day</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having indications for ICSI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any known contraindications to the approved fertility drugs.&#xD;
  &#xD;
            2. Severe endometriosis.&#xD;
  &#xD;
            3. Uterine malformations or abnormal uterine cavity.&#xD;
  &#xD;
            4. Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.&#xD;
  &#xD;
            5. Severe male factor for infertility.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beni Suef University</last_name>
        <phone>082 2356845</phone>
        <phone_ext>2</phone_ext>
        <email>info@bsu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Dydrogesterone</keyword>
    <keyword>Intra Cytoplasmic Sperm Injection</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triptorelin Pamoate</mesh_term>
      <mesh_term>Cetrorelix</mesh_term>
      <mesh_term>Dydrogesterone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05972902
  org study id: Dydrogesterone IVF
  nct id: NCT05972902
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention
        of premature LH surge and quality of retrieved oocytes and embryos in women undergoing
        intra-cytoplasmic sperm injection.
  Study Design:
  
        A randomized clinical trial (RCT).
  
        Study Site:
  
        The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques
        center. The study population includes all infertile women undergoing IVF at Beni-Suef
        University ART center will be included. Women will be recruited for enrollment when they come
        to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to
        participate in the study after been evaluated to ensure fulfilling inclusion and exclusion
        criteria.
  
        Study Sample:
  
        The study consisted of 387 women which will be randomized into 3 groups. Women will be
        enrolled in the study after giving written informed consent. Group (A): 129 Women will start
        Dydrogesterone group. Group (B): 129 Women will undergo Agonist protocol group. Group (c):
        129 Women will undergo Antagonist protocol group.
  
        Study Procedure:
  
        Full history taking. Systematic clinical examination to assess the general condition, body
        mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2
        to 3 of menstruation. Routine labs as CBC, liver & kidney functions to exclude general
        disease as a contraindication for induction or pregnancy. Blood sample obtained for
        assessment of basal serum levels of FSH, LH, PRL, AMH and E2 on day 3 of the cycle.
  
        Ovarian Stimulation:
  
        #Treatment protocols: The patients begins injections of recombinant FSH (rFSH, Gonal-F;
        Merck- Serono, Italy) or human menopausal gonadotropin (hp-hMG, Menopur; Ferring
        Pharmaceuticals, Geneva,Switzerland) since day 2-3 of menstruation, with daily dose of
        150-450 IU adjusted according to individual conditions on the basis of the antral follicle
        count (AFC), age of the woman, body mass index (BMI), and previous ovarian response,
        according to the standard operating procedures of the center.
  
        For pituitary suppression, the patients received:
  
          -  Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since
             day 2-3.
  
          -  GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously
             since the dominant follicles reached the diameter of 12-14 mm till trigger day.
  
          -  GnRH agonist (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of
             the cycle prior to stimulation. The serum LH, estradiol and progesterone levels as well
             as number and size of follicles will be monitored every 1 to 2 days, starting from
             stimulation day 5 until the day of hCG injection. The daily dose of rFSH will be
             adjusted according to patient' s ovarian response, based on serum estradiol levels and
             the number and size of ovarian follicles as measured by transvaginal ultrasonography.
  
        Triggering and Ovum pick uptake:
  
        Triptorelin (0.2 mg; Decapeptyl, Ferring Pharmaceuticals, the Netherlands) or human chorionic
        gonadotropin (10000 IU; Choriomon) or Ovitrel 250 mg (Merck Serono, Italy) are given to
        trigger final maturation of the oocytes. Oocyte retrieval was performed approximately 36
        hours later.
  
        Fresh and Frozen Embryo Transfer:
  
        A maximum of 2 embryos will be transferred on day 3 after retrieval under transabdominal
        ultrasound guidance. Day 3 -5 embryos in the antagonist group and all the viable embryos or
        blastocysts in the duphaston group are cryopreserved using vitrification.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of oocytes retrieved.
  time frame: 1cycle (1 month)
  description: number of oocytes
  measure: maturity of oocytes retrieved.
  time frame: 1 cycle (1month)
  description: either M2 or M1
  measure: Duration of stimulation
  time frame: 1 ICSI cycle (1 month)
  description: days till trigger
  arm group label: Dydrogesterone
  arm group type: Experimental
  description: For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.
  arm group label: GnRH antagonist
  arm group type: Active Comparator
  description: For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.
  arm group label: GnRH agonist
  arm group type: Active Comparator
  description: For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation
  intervention type: Drug
  intervention name: Dydrogesterone
  description: Dydrogesterone molecular structure and pharmacologic effects are closely related to endogenous progesterone
  arm group label: Dydrogesterone
  other name: Duphaston
  intervention type: Drug
  intervention name: Cetrorelix acetate
  description: GnRH antagonist
  arm group label: GnRH antagonist
  other name: cetrotide
  intervention type: Drug
  intervention name: Triptorelin
  description: GnRH agonist
  arm group label: GnRH agonist
  other name: Decapeptyl, sc 0.1 mg/day
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Triptorelin Pamoate
  mesh term: Cetrorelix
  mesh term: Dydrogesterone
  sharing ipd: Undecided