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

Phase 1

Recruiting

• Conditions: Fertility Issues; Infertility; Infertility, Female
• Interventions: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serum LH, E2, P4; Drug: Estradiol Valerate 2 MG; Drug: Progesterone 100 Mg Vaginal Insert; Diagnostic Test: Serum P4 day of ET; Procedure: Embryo transfer

• Registration Number: NCT05980091
• Lead Sponsor: ART Fertility Clinics LLC

Brief 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.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-07
• Study Start: 2023-09-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 316

Inclusion Criteria

• Women aged 18 years to 43 years.
• Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
• Endometrial trilaminar appearance on the day of progesterone start

Exclusion Criteria

• Uterine abnormality

• Hydrosalpinx

• Asherman syndrome

• Any known contraindications or allergy to oral estradiol or progesterone.

• Intention to treat : exclusion factors :

  1. Spontaneous ovulation HRT cycle
  2. Discontinuation of HRT medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Embryo transfer	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group A	Serum P4 day of ET	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group A	Transvaginal ultrasound	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group A	Serum LH, E2, P4	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group A	Estradiol Valerate 2 MG	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group A	Progesterone 100 Mg Vaginal Insert	Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
Group B	Transvaginal ultrasound	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Group B	Serum LH, E2, P4	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Group B	Estradiol Valerate 2 MG	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Group B	Progesterone 100 Mg Vaginal Insert	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Group B	Serum P4 day of ET	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
Group B	Embryo transfer	Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)

Primary Outcome Measures

Name	Time	Method
Livebirth rate (LBR)	41 weeks	Defined as the delivery of a live infant born after 24 completed weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	5 weeks	Ultrasonographic sac visible at 5 gestational weeks
Biochemical pregnancy rate	5 weeks	Positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen but without a further development into a clinical pregnancy)
Ongoing pregnancy rate after 12 weeks	13 weeks	Viable pregnancy with a gestational age of more than 12 weeks
Miscarriage rate	24 weeks	Spontaneous loss of a clinical pregnancy before 24 completed weeks of gestation

Trial Locations

Locations (2)

ART Fertility Clinics Dubai; 🇦🇪 Dubai, United Arab Emirates

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates