NCT05980091

Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.

Optimal Timing of Euploid Day 6 Blastocyst (blastocyst Which Was Biopsied on Day 6 After Fertilization) Transfer in Frozen Hormonal Replacement Therapy Cycles: Day 6 or Day 7 of Progesterone Administration?

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: ART Fertility Clinics LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective \& randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.

Detailed description

Traditionally the duration of progesterone exposure before embryo transfer has been considered equal for day 5 and day 6 embryos but this may not be the case and warrants further study. The optimal preparation of the endometrium in frozen embryo transfer (FET) cycles is yet to be determined. Synchronization between the embryonic stage and the endometrial window of implantation (WOI) is crucial and progesterone plays a critical role in the WOI (1). Data on the optimal route of administration, the dose and duration of progesterone supplementation before blastocyst transfer are inconsistent (2,3). In view of the current lack of evidence, this study will be of importance.

Conditions

• Infertility
• Fertility Issues
• Infertility, Female

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transvaginal ultrasound	Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
DIAGNOSTIC_TEST	Serum LH, E2, P4	In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
DRUG	Estradiol Valerate 2 MG	Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses. Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
DRUG	Progesterone 100 Mg Vaginal Insert	The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
DIAGNOSTIC_TEST	Serum P4 day of ET	On the day of embryo transfer (ET), a blood test is taken to measure serum P4
PROCEDURE	Embryo transfer	Procedure in which embryo is transferred into the uterus

Timeline

• Start date: 2023-09-22
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-08-07
• Last updated: 2025-02-21

Locations

2 sites across 1 country: United Arab Emirates