Clinical trial

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?

Name

2306-ABU-013-CC

Description

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.

Trial arms

Trial start

2023-09-22

Estimated PCD

2024-04-30

Trial end

2024-09-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Group A, Group B

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

Arms:

Group A, Group B

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)

Arms:

Group A, Group B

Other names:

Estradiol Valerate

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

Arms:

Group A, Group B

Other names:

Progesterone 100 mg

Serum P4 day of ET

On the day of embryo transfer (ET), a blood test is taken to measure serum P4

Arms:

Group A, Group B

Embryo transfer

Procedure in which embryo is transferred into the uterus

Arms:

Group A, Group B

Other names:

Size

316

Primary endpoint

Livebirth rate (LBR)

41 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 316, 'type': 'ESTIMATED'}}

Updated at

2023-12-07

1 organization

2 products

3 indications

Organization

ART Fertility Clinics

Product

Indication

Indication

Indication

Product