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/NCT06020924</url>
    </required_header>
    <id_info>
      <org_study_id>UF1.0</org_study_id>
      <nct_id>NCT06020924</nct_id>
    </id_info>
    <brief_title>The Effects of Uterine Fibroids on Pregnancy in Women</brief_title>
    <official_title>The Effects of Uterine Fibroids on Pregnancy in Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wenwen Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Huazhong University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Female fertility may be affected by uterine fibroids, although this association has not been&#xD;
        elucidated. This retrospective cohort study aims to evaluate the impact of fibroids on women&#xD;
        fertility.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Infertility is defined as the inability of a couple to achieve pregnancy over an average&#xD;
        period of one year of unprotected sexual intercourse. Currently, one in six couples is&#xD;
        affected by infertility worldwide. With the development of society bringing enormous material&#xD;
        and spiritual wealth to human beings, comprehensive factors such as environmental pollution,&#xD;
        life and work pressure and bad habits have an important impact on fertility. Infertility is a&#xD;
        disease that seriously affects the physical and mental health of patients and brings about&#xD;
        serious social problems. According to the World Health Organization (WHO), infertility will&#xD;
        become the third major disease in the 21st century following tumor and cardiovascular&#xD;
        diseases.&#xD;
  &#xD;
        Infertility can be caused by a single factor or multiple factors together. The WHO proposed a&#xD;
        classification method based on etiological diagnosis to classify infertility into six major&#xD;
        causes: ovulation factors, fallopian tube problems, uterine factors, cervical factors, male&#xD;
        factors and psychosocial factors. There is a serious impact on female fertility due to&#xD;
        heredity, auto-immunity, infection, metabolic abnormalities, surgery and other factors. The&#xD;
        main factors leading to female infertility include patient age, education level, weight&#xD;
        (obesity), menstrual history (irregular menstrual cycle), pregnancy history (stillbirth and&#xD;
        abortion history), disease history (ovarian cyst, ovarian aging, endocrine autoimmune&#xD;
        diseases, fallopian tube abnormalities, pelvic abnormalities and uterine abnormalities),&#xD;
        sexual history, previous surgical history, smoking history, chemical exposure history, and&#xD;
        mental stress, etc. The objective of this study is to explore the impact of uterine fibroids&#xD;
        on female pregnancy rate.&#xD;
  &#xD;
        Uterine fibroid is a common benign tumor of female reproductive tract, with 25% to 50% of&#xD;
        women of childbearing age suffering from uterine fibroid. The fibroids can cause various&#xD;
        clinical symptoms, including menorrhagia, prolonged menstruation, pelvic compression and&#xD;
        pain, as well as infertility and obstetric complications, but mostly are asymptomatic. The&#xD;
        prevalence of fibroids increases with the age of women, while the fertility rate declines&#xD;
        with ages. This complex relationship is particularly harmful. The mechanisms related to&#xD;
        fibroids and infertility vary with the type and location of fibroids, including anatomical&#xD;
        structure deformation, and interference with the physiological changes of endometrium and&#xD;
        implantation of zygotes. In addition, fibroids can destroy the anatomical structure of the&#xD;
        pelvis and disrupt the function of the fallopian tube. The FIGO classification describes nine&#xD;
        types of fibroids: submucosal fibroids (type 0, Ⅰ, Ⅱ), intramural fibroids (types Ⅲ, Ⅳ, Ⅴ),&#xD;
        and subserous fibroids (types Ⅵ and Ⅶ). Among them, submucosal and some intramural fibroids&#xD;
        can lead to endometrial inflammatory environment, affecting sperm migration and embryo&#xD;
        implantation.&#xD;
  &#xD;
        Nevertheless, there is still controversy in epidemiological studies regarding the&#xD;
        relationship between uterine fibroids and female infertility. Parity has a significant&#xD;
        protective effect against fibroid development, and in fact infertile women may be at higher&#xD;
        risk for fibroids. Similarly, it is difficult to distinguish whether fibroids have a direct&#xD;
        deleterious effect on infertility, or whether the fibroid-infertility association is mediated&#xD;
        by concomitant factors that affect fertility. In addition, the impact of each type of&#xD;
        fibroids on fertility varies by the difference in the number, size, and location of fibroids,&#xD;
        and the combinations of different fibroids may have special effects. Do uterine fibroids&#xD;
        already exist when women plan and attempt to conceive? Do uterine fibroids have negative&#xD;
        effects on fertility during this period? It is an urgent need to solve this problem at the&#xD;
        present. Therefore, this study is of great significance for us to understand the impact of&#xD;
        fibroids on female fertility and guide the treatment patterns of female patients with uterine&#xD;
        fibroids who have fertility needs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The pregnancy rate varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Fibroid types range from 0 to 8 according to the FIGO classification. The pregnancy rate varies with different types and size of fibroids. Subserosal fibroids do not exert any detrimental effects on fertility outcomes. Submucosal fibroids have negatively impact fertility. The effect of intramural fibroids on reproductive outcome has been a subject of debate in the past, but recent literature indicates that intramural myomas also negative impact fertility.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The rate of spontaneous abortion varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Fibroids are a source of several obstetric complications, including spontaneous abortion, preterm birth, cesarean section, placental abruption, postpartum hemorrhage, and breech presentation. Submucosal fibroids and multiple myomas have an increased risk of miscarriage. The rate is calculated as the proportion of the number of miscarriage to the total number of pregnancies in different types of fibroids.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of preterm birth varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Fibroids measuring more than 5 centimetre (cm) have been linked to delivery at earlier gestational age. The ratio is calculated as the proportion of fibroids combined with preterm birth to fibroids combined with live birth.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of cesarean section varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Greater size and number of fibroids were associated with increased incidence of cesarean delivery. The ratio is calculated as the proportion of fibroids combined with cesarean section to total births.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of placental abruption varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Fibroids have an increased risk of placental abruption in patients. The ratio is calculated as the proportion of fibroids combined with placental abruption to total patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of postpartum hemorrhage varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>There is an independent association of uterine leiomyomata with increased risk of severe postpartum hemorrhage. Submucosal fibroids are less implicated in bleeding events than intramural and subserosal ones. Great rates of hemorrhage are related with the biggest lesions. The ratio is calculated as the proportion of fibroids combined with postpartum hemorrhage to total patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of malpresentation varies with different types and size of fibroids.</measure>
      <time_frame>through study completion, an average of 2.5 year</time_frame>
      <description>Patients with fibroids have an increased risk of breech presentation. Malpresentation may be more related to multiple fibroids an to those bigger than 10 cm. The ratio is calculated as the proportion of fibroids combined with malpresentation to total patients.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1658</enrollment>
    <condition>Female Infertility</condition>
    <condition>Uterine Fibroid</condition>
    <arm_group>
      <arm_group_label>UFs with infertile patients</arm_group_label>
      <description>Uterine fibroids combined with infertile women</description>
    </arm_group>
    <arm_group>
      <arm_group_label>UFs with non-infertile patients</arm_group_label>
      <description>Uterine fibroids combined with non-infertile women</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>This study is a retrospective observational study without intervention.</description>
      <arm_group_label>UFs with infertile patients</arm_group_label>
      <arm_group_label>UFs with non-infertile patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Female patients with uterine fibroids&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 20-50 years&#xD;
  &#xD;
            2. Diagnosed with uterine fibroids (by ultrasound or pathology) combined with infertile&#xD;
               or non-infertile patients&#xD;
  &#xD;
            3. Complete clinical data.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe infectious disease or rheumatic immune disease active stage&#xD;
  &#xD;
            2. Previous history of malignant tumors&#xD;
  &#xD;
            3. Incomplete clinical data.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shixuan Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huazhong University of Science and Technology, Wuhan, Hubei, China, 430000</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shixuan Wang</last_name>
      <phone>86-27-83663078</phone>
      <email>shixuanwang@tjh.tjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shixuan Wang, PhD</last_name>
        <phone>86-27-83663078</phone>
        <email>shixuanwang@tjh.tjmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Wenwen Wang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Infertility</keyword>
    <keyword>Uterine fibroids</keyword>
    <keyword>Pregnancy rate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leiomyoma</mesh_term>
      <mesh_term>Myofibroma</mesh_term>
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Infertility, Female</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06020924
  org study id: UF1.0
  nct id: NCT06020924
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Female fertility may be affected by uterine fibroids, although this association has not been
        elucidated. This retrospective cohort study aims to evaluate the impact of fibroids on women
        fertility.
  Infertility is defined as the inability of a couple to achieve pregnancy over an average
        period of one year of unprotected sexual intercourse. Currently, one in six couples is
        affected by infertility worldwide. With the development of society bringing enormous material
        and spiritual wealth to human beings, comprehensive factors such as environmental pollution,
        life and work pressure and bad habits have an important impact on fertility. Infertility is a
        disease that seriously affects the physical and mental health of patients and brings about
        serious social problems. According to the World Health Organization (WHO), infertility will
        become the third major disease in the 21st century following tumor and cardiovascular
        diseases.
  
        Infertility can be caused by a single factor or multiple factors together. The WHO proposed a
        classification method based on etiological diagnosis to classify infertility into six major
        causes: ovulation factors, fallopian tube problems, uterine factors, cervical factors, male
        factors and psychosocial factors. There is a serious impact on female fertility due to
        heredity, auto-immunity, infection, metabolic abnormalities, surgery and other factors. The
        main factors leading to female infertility include patient age, education level, weight
        (obesity), menstrual history (irregular menstrual cycle), pregnancy history (stillbirth and
        abortion history), disease history (ovarian cyst, ovarian aging, endocrine autoimmune
        diseases, fallopian tube abnormalities, pelvic abnormalities and uterine abnormalities),
        sexual history, previous surgical history, smoking history, chemical exposure history, and
        mental stress, etc. The objective of this study is to explore the impact of uterine fibroids
        on female pregnancy rate.
  
        Uterine fibroid is a common benign tumor of female reproductive tract, with 25% to 50% of
        women of childbearing age suffering from uterine fibroid. The fibroids can cause various
        clinical symptoms, including menorrhagia, prolonged menstruation, pelvic compression and
        pain, as well as infertility and obstetric complications, but mostly are asymptomatic. The
        prevalence of fibroids increases with the age of women, while the fertility rate declines
        with ages. This complex relationship is particularly harmful. The mechanisms related to
        fibroids and infertility vary with the type and location of fibroids, including anatomical
        structure deformation, and interference with the physiological changes of endometrium and
        implantation of zygotes. In addition, fibroids can destroy the anatomical structure of the
        pelvis and disrupt the function of the fallopian tube. The FIGO classification describes nine
        types of fibroids: submucosal fibroids (type 0, Ⅰ, Ⅱ), intramural fibroids (types Ⅲ, Ⅳ, Ⅴ),
        and subserous fibroids (types Ⅵ and Ⅶ). Among them, submucosal and some intramural fibroids
        can lead to endometrial inflammatory environment, affecting sperm migration and embryo
        implantation.
  
        Nevertheless, there is still controversy in epidemiological studies regarding the
        relationship between uterine fibroids and female infertility. Parity has a significant
        protective effect against fibroid development, and in fact infertile women may be at higher
        risk for fibroids. Similarly, it is difficult to distinguish whether fibroids have a direct
        deleterious effect on infertility, or whether the fibroid-infertility association is mediated
        by concomitant factors that affect fertility. In addition, the impact of each type of
        fibroids on fertility varies by the difference in the number, size, and location of fibroids,
        and the combinations of different fibroids may have special effects. Do uterine fibroids
        already exist when women plan and attempt to conceive? Do uterine fibroids have negative
        effects on fertility during this period? It is an urgent need to solve this problem at the
        present. Therefore, this study is of great significance for us to understand the impact of
        fibroids on female fertility and guide the treatment patterns of female patients with uterine
        fibroids who have fertility needs.
  observational model: Case-Control
  time perspective: Retrospective
  measure: The pregnancy rate varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Fibroid types range from 0 to 8 according to the FIGO classification. The pregnancy rate varies with different types and size of fibroids. Subserosal fibroids do not exert any detrimental effects on fertility outcomes. Submucosal fibroids have negatively impact fertility. The effect of intramural fibroids on reproductive outcome has been a subject of debate in the past, but recent literature indicates that intramural myomas also negative impact fertility.
  measure: The rate of spontaneous abortion varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Fibroids are a source of several obstetric complications, including spontaneous abortion, preterm birth, cesarean section, placental abruption, postpartum hemorrhage, and breech presentation. Submucosal fibroids and multiple myomas have an increased risk of miscarriage. The rate is calculated as the proportion of the number of miscarriage to the total number of pregnancies in different types of fibroids.
  measure: The rate of preterm birth varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Fibroids measuring more than 5 centimetre (cm) have been linked to delivery at earlier gestational age. The ratio is calculated as the proportion of fibroids combined with preterm birth to fibroids combined with live birth.
  measure: The rate of cesarean section varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Greater size and number of fibroids were associated with increased incidence of cesarean delivery. The ratio is calculated as the proportion of fibroids combined with cesarean section to total births.
  measure: The rate of placental abruption varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Fibroids have an increased risk of placental abruption in patients. The ratio is calculated as the proportion of fibroids combined with placental abruption to total patients.
  measure: The rate of postpartum hemorrhage varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: There is an independent association of uterine leiomyomata with increased risk of severe postpartum hemorrhage. Submucosal fibroids are less implicated in bleeding events than intramural and subserosal ones. Great rates of hemorrhage are related with the biggest lesions. The ratio is calculated as the proportion of fibroids combined with postpartum hemorrhage to total patients.
  measure: The rate of malpresentation varies with different types and size of fibroids.
  time frame: through study completion, an average of 2.5 year
  description: Patients with fibroids have an increased risk of breech presentation. Malpresentation may be more related to multiple fibroids an to those bigger than 10 cm. The ratio is calculated as the proportion of fibroids combined with malpresentation to total patients.
  arm group label: UFs with infertile patients
  description: Uterine fibroids combined with infertile women
  arm group label: UFs with non-infertile patients
  description: Uterine fibroids combined with non-infertile women
  intervention type: Other
  intervention name: No intervention
  description: This study is a retrospective observational study without intervention.
  arm group label: UFs with infertile patients
  arm group label: UFs with non-infertile patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shixuan Wang
  role: Principal Investigator
  affiliation: Huazhong University of Science and Technology, Wuhan, Hubei, China, 430000
  last name: Shixuan Wang
  phone: 86-27-83663078
  email: shixuanwang@tjh.tjmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Wenwen Wang
  investigator title: Professor
  mesh term: Leiomyoma
  mesh term: Myofibroma
  mesh term: Infertility
  mesh term: Infertility, Female
  sharing ipd: No