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

February 20, 2025 updated by: ART Fertility Clinics LLC

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

316

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)
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)

Other Names:
  • Estradiol Valerate
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
Other Names:
  • Progesterone 100 mg
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
Other Names:
  • ET
Other: Group B
Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)
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)

Other Names:
  • Estradiol Valerate
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
Other Names:
  • Progesterone 100 mg
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
Other Names:
  • ET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Livebirth rate (LBR)
Time Frame: 41 weeks
Defined as the delivery of a live infant born after 24 completed weeks of gestation
41 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Carol Coughlan, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2306-ABU-013-CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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