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CS Scar Impact on ART Outcomes

Sponsor
HealthPlus Fertility Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT06021886
Collaborator
(none)
510
Enrollment
1
Location
6.6
Anticipated Duration (Months)
77.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways; increase difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect the chances of embryo implantation and increase the rate of spontaneous miscarriages To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome? All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who meet the inclusion criteria will be included in the study.

    • Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI less tha 30 kg/m2 Hormone therapy preparation for FET.

    • Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or adenomyosis Hydrosalpinx, Chronic endometritis

    • Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart rate at 7 weeks of gestation or beyond.

    • Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage. Caesarean section scar dehiscence or

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    510 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    CS Scar Impact on ART Outcomes
    Actual Study Start Date :
    Jun 15, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patient without scar

    history of euploid embryo transfer
    patient with cs scar no Niche

    history of euploid embryo transfer
    patient with cs scar with niche

    history of euploid embryo transfer

    Outcome Measures

    Primary Outcome Measures

    1. CS scar impact on ART outcomes, Retrospective Cohort Study [2015 to 2022,]

      Clinical pregnancy rate

    Secondary Outcome Measures

    1. ART outcomes [2015 to 2022,]

      Early pregnancy complications: Ectopic pregnancy or Miscarriage. Caesarean section scar dehiscence or rupture. Presence of intrauterine fluid accumulation at the time of ET. Endometrial thickness at the time of ET. Live birth.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 25-40 years old.

    Euploid embryo transfer.

    Medically free

    BMI less tha 30 kg/m2

    Hormone therapy preparation for FET.

    Exclusion Criteria:
    • Exclusion criteria

    Previous uterine scar other than cesarean section.

    Congenital uterine abnormalities

    Presence of intrauterine lesions e.g., polyp, fibroid,

    Endometriosis or adenomyosis

    Hydrosalpinx, Chronic endometritis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HealthPlus fertility Centre Abu Dhabi United Arab Emirates

    Sponsors and Collaborators

    • HealthPlus Fertility Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Elsayed Hassan Hamed Elbohoty, Reproductive medicine consultant, HealthPlus Fertility Center
    ClinicalTrials.gov Identifier:
    NCT06021886
    Other Study ID Numbers:
    • REC/2023/P38
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Elsayed Hassan Hamed Elbohoty, Reproductive medicine consultant, HealthPlus Fertility Center
    CS Scar Impact on ART Outcomes
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Sep 1, 2023