Effect of Embryo Migration in Fresh Oocyte Donation Cycles

Effect of Embryo Migration After Embryo Transfer With Fresh Oocyte Donation Cycles on Pregnancy Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility

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 Type: Observational
• Enrollment (Anticipated): 653

Contacts and Locations

Study Locations

• Cyprus
  • Kyrenia, Cyprus
    • Recruiting
    • Dunya In vitro fertilization center
    • Contact: Alper Eraslan, M.D.; Phone Number: +90 533 888 11 14; Email: alpereraslan1984@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study included fresh OD cycles of recipient women.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
live birth rate	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	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.	1 year

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

General Publications

• Saravelos SH, Wong AW, Chan CP, Kong GW, Cheung LP, Chung CH, Chung JP, Li TC. Assessment of the embryo flash position and migration with 3D ultrasound within 60 min of embryo transfer. Hum Reprod. 2016 Mar;31(3):591-6. doi: 10.1093/humrep/dev343. Epub 2016 Jan 11.
• Ficicioglu C, Ozcan P, Kocer MG, Yesiladali M, Alagoz O, Ozkara G, Tayyar AT, Altunok C. Effect of air bubbles localization and migration after embryo transfer on assisted reproductive technology outcome. Fertil Steril. 2018 Feb;109(2):310-314.e1. doi: 10.1016/j.fertnstert.2017.10.032. Epub 2018 Jan 4.
• Ozdemir AZ, Ayas B, Guven D, Turkmen A. Embryo flash migration in fresh and frozen embryo transfers for day 3 and day 5 embryos. Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:33-37. doi: 10.1016/j.ejogrb.2019.04.025. Epub 2019 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 25, 2021

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: embryo transfer; live birth rate; embryo migration; fresh oocyte donation cycle
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: YDU/2020/86-1239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After results are obtained we will decide.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No