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

ART Fertility Clinics LLC

Status and phase: Enrolling; Phase 1

Conditions: Infertility; Fertility Issues; Infertility, Female

Treatments: Diagnostic Test: Serum P4 day of ET; Diagnostic Test: Transvaginal ultrasound; Drug: Progesterone 100 Mg Vaginal Insert; Procedure: Embryo transfer; Drug: Estradiol Valerate 2 MG; Diagnostic Test: Serum LH, E2, P4

Study type: Interventional

Funder types: Other

Identifiers

NCT05980091

2306-ABU-013-CC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 2 patient groups

Group A

Other group

Description:

Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)

Treatment:

Diagnostic Test: Serum LH, E2, P4

Drug: Estradiol Valerate 2 MG

Procedure: Embryo transfer

Drug: Progesterone 100 Mg Vaginal Insert

Diagnostic Test: Serum P4 day of ET

Diagnostic Test: Transvaginal ultrasound

Group B

Other group

Description:

Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)

Treatment:

Diagnostic Test: Serum LH, E2, P4

Drug: Estradiol Valerate 2 MG

Procedure: Embryo transfer

Drug: Progesterone 100 Mg Vaginal Insert

Diagnostic Test: Serum P4 day of ET

Diagnostic Test: Transvaginal ultrasound