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Effect of Embryo Migration in Fresh Oocyte Donation Cycles

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04855669
Collaborator
(none)
653
Enrollment
1
Location
66.8
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(ET), on clinical pregnancy rates(CPR) and live birth rates(LBR) in fresh oocyte donation(OD) cycles.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Embryos were considered to be staying at the initial expulsion site for long years. However, in 1976 Edwards and Steptoe reported a tubal ectopic pregnancy after in vitro fertilization (IVF) with a day-3 embryo transfer, which may be accepted as the earliest evidence for migration of embryos from the cavity. The migration concept is very recently taken into consideration by few authors, with studies on fresh IVF and frozen ET cycles.

    Oocyte donation (OD) is a method of ART, in which by using young oocytes from donors the embryo quality is optimized. OD cycles have high LBRs, and are the choice of treatment in advanced reproductive age, repeated IVF failure, premature ovarian insufficiency(POI) and particular heritable genetic diseases. Donor oocytes can be used as fresh or cryoprotected-thawed, where fresh oocytes have higher LBRs.

    In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on CPR and LBR.

    Therefore, the investigators conducted this study to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal USG guided ET, on CPR and LBR in fresh OD cycles. In literature, this study is first to focus on embryo migration and LBR in fresh OD cycles.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    653 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Embryo Migration After Embryo Transfer With Fresh Oocyte Donation Cycles on Pregnancy Outcomes
    Actual Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Jun 1, 2021
    Anticipated Study Completion Date :
    Jul 25, 2021

    Outcome Measures

    Primary Outcome Measures

    1. live birth rate [1 year]

      In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on live birth rate outcome.

    Secondary Outcome Measures

    1. clinical pregnancy rate [1 year]

      In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on clinical pregnancy and miscarriage rate outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • fresh oocyte donation cycles

    • Anatomically anteverted-anteflexed recipient uterus

    • partners with normal sperm parameters

    Exclusion Criteria:

    • Data of women who did not give approval

    • IVF cycles

    • frozen-thawed embryo transfer cycles

    • cryopreserved-thawed OD cycles

    • abnormal sperm parameters or need of any testicular interventions

    • Anatomically retroverted-retroflexed recipient uterus

    • teneculum required embryo transfers

    • difficult transfers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dunya In vitro fertilization center Kyrenia Cyprus

    Sponsors and Collaborators

    • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turkan Gursu, Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT04855669
    Other Study ID Numbers:
    • YDU/2020/86-1239
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Turkan Gursu, Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
    embryo migration
    embryo transfer
    fresh oocyte donation cycle
    live birth rate
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Apr 22, 2021