Actively Recruiting

Phase 1
Age: 18Years - 43Years
FEMALE
Healthy Volunteers
ID05980091

Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen Hormonal Replacement Therapy Cycles: Comparing Day 6 versus Day 7 of Progesterone Administration

Led by ART Fertility Clinics LLC · Updated on 2025-02-21

316

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the timing of transferring euploid day 6 blastocysts in frozen Hormonal Replacement Therapy (HRT) cycles, specifically whether transfer on the 6th or 7th day of progesterone exposure leads to better outcomes in clinical pregnancy, miscarriage, and live birth rates. This study is the first to focus exclusively on euploid day 6 blastocysts to remove the effect of aneuploidy on implantation failure and miscarriage. The timing of progesterone exposure is randomized at the start of progesterone treatment. Participants will receive estradiol valerate starting on day 2 or 3 of menstruation, increasing to a daily dose of 6 mg. Progesterone vaginal suppositories begin when the endometrium shows optimal thickness and a trilaminar appearance, starting with 100 mg doses twice on day 1 and then three times daily from day 2. Embryo transfer is scheduled either on the 6th or 7th full day after starting progesterone. Throughout the HRT cycle, participants undergo transvaginal ultrasounds and blood tests measuring hormone levels, including serum progesterone on the day of embryo transfer. Participants will be monitored with ultrasounds and hormone tests to track endometrial development and hormone levels. The primary outcome measured is live birth rate at 41 weeks. Secondary outcomes include biochemical pregnancy rates, clinical pregnancy rates, ongoing pregnancy rates at 13 weeks, and miscarriage rates at 24 weeks. The study involves careful monitoring to exclude ovarian follicles and assess hormone levels to optimize timing of embryo transfer. Total participation duration is aligned with pregnancy outcomes and follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 43Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Uterine abnormality
  • Hydrosalpinx
  • Asherman syndrome
  • Any known contraindications or allergy to oral estradiol or progesterone
  • Spontaneous ovulation during HRT cycle
  • Discontinuation of HRT medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants receive hormonal replacement therapy with estradiol valerate and progesterone to prepare the endometrium for embryo transfer. The timing of embryo transfer is either on the 6th or 7th full day of progesterone administration depending on group assignment.

Multiple visits for hormone monitoring and embryo transfer procedure

Follow-up

Duration - Up to 41 weeks

Participants are followed for pregnancy outcomes including biochemical and clinical pregnancy rates, ongoing pregnancy, miscarriage, and live birth.

Several visits up to 41 weeks for pregnancy monitoring

Trial Site Locations

Total: 2 locations

1

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202

Actively Recruiting

2

ART Fertility Clinics Dubai

Dubai, United Arab Emirates

Actively Recruiting

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Research Team

B

Barbara Lawrenz, PhD

J

Jonalyn Edades, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo.

Jason M Franasiak, Maria Ruiz-Alonso, Richard T Scott...

https://pubmed.ncbi.nlm.nih.gov/26940791

What is the 'ideal' duration of progesterone supplementation before the transfer of cryopreserved-thawed embryos in estrogen/progesterone replacement protocols?

Frank Nawroth, Michael Ludwig

https://pubmed.ncbi.nlm.nih.gov/15695314

Vitrified-warmed blastocyst transfer on the 5th or 7th day of progesterone supplementation in an artificial cycle: a randomised controlled trial.

A van de Vijver, P Drakopoulos, N P Polyzos...

https://pubmed.ncbi.nlm.nih.gov/28443690

Frozen-warmed blastocyst transfer after 6 or 7 days of progesterone administration: impact on live birth rate in hormone replacement therapy cycles.

Caroline Roelens, Samuel Santos-Ribeiro, Lauren Becu...

https://pubmed.ncbi.nlm.nih.gov/32553469

Day 5 versus Day 6 blastocyst transfers: a systematic review and meta-analysis of clinical outcomes.

Mathilde Bourdon, Khaled Pocate-Cheriet, Astri Finet de Bantel...

https://pubmed.ncbi.nlm.nih.gov/31644803