Actively Recruiting

Phase Not Applicable
Age: 18Years - 42Years
FEMALE
ID06239376

The Effectiveness of Two Different Endometrial Preparation Regimens for Frozen Embryo Transfer in Women With Adenomyosis

Led by Mỹ Đức Hospital · Updated on 2026-03-20

222

Participants Needed

1

Research Sites

37 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating two different protocols for preparing the uterus lining (endometrium) before frozen embryo transfer (FET) in women with adenomyosis undergoing IVF/ICSI. The study aims to find out if combining GnRH agonist and letrozole with hormone therapy leads to higher live birth rates compared to hormone therapy alone. It also looks at the side effects of the combined protocol. Adenomyosis, a condition where uterine tissue invades muscle layers, can cause infertility and pregnancy complications, and optimal preparation methods are unclear. Participants are randomly assigned to one of two groups. The first group receives two doses of GnRH agonist injections and daily letrozole over two months before starting hormone therapy with oral estradiol and vaginal progesterone. The second group receives hormone therapy alone starting early in the menstrual cycle with oral estradiol followed by vaginal progesterone once the uterine lining is thick enough. Embryo thawing and transfer are timed with progesterone start. Hormonal support continues until the 12th week of pregnancy. Participants undergo screening and ultrasound to confirm adenomyosis and monitor uterine lining thickness. Various pregnancy outcomes, including live birth rate at 22 weeks, pregnancy tests, implantation, miscarriage, and birth weight, are tracked. Side effects from the treatments and pregnancy complications like gestational diabetes and hypertension are also monitored. The study includes careful follow-up until delivery and newborn health assessments. Total participation duration covers preparation, pregnancy monitoring, and birth outcomes.

CONDITIONS

Brief Title

Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients

Who Can Participate

Age: 18Years - 42Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of adenomyosis by transvaginal ultrasound or pelvic MRI
  • Age between 18 and 42 years
  • Have undergone three or fewer previous IVF cycles
  • Planned for frozen embryo transfer
  • Agree to transfer no more than two day-3 embryos or one blastocyst (day 5 or 6)
  • Not participating in any other clinical study
Not Eligible

You will not qualify if you...

  • Embryos from in vitro maturation (IVM) cycles
  • Uterine or adnexal abnormalities such as intrauterine adhesions, unicornuate, bicornuate, or arcuate uterus; unremoved hydrosalpinx; endometrial polyps; submucosal leiomyoma; or leiomyoma distorting the uterine cavity
  • Contraindications to hormone treatments like breast cancer or risk of venous thromboembolism
  • Embryos from oocyte donation cycles
  • History of GnRH agonist injection within three months before screening

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit conducted on days 2 to 4 of the menstrual cycle

Pre-treatment (GnRH agonist + Letrozole) for GnRHa+AI - AC group

Duration - Approximately 56 days

Participants in this group receive two injections of GnRH agonist and take daily Letrozole to prepare for endometrial treatment.

2 injections on days 2-4 of menstrual cycle and 28 days later; Letrozole taken daily during this period

Artificial Cycle Endometrial Preparation

Duration - At least 9 days before progesterone initiation

Participants start oral estradiol valerate to prepare the endometrium. Endometrial thickness is monitored, and vaginal progesterone is initiated once thickness reaches 7 mm or more.

Monitoring from day 10 of estradiol priming; 1 visit for thickness monitoring before progesterone start

Embryo Transfer and Luteal Phase Support

Duration - Up to 12 weeks of gestation

Embryo transfer is scheduled based on progesterone initiation and embryo stage. Hormonal support continues until the 12th week of gestation.

Visits aligned with embryo transfer and hormonal support follow-up until week 12

Trial Site Locations

Total: 1 location

1

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam, 70000

Actively Recruiting

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Research Team

T

Tien K Le, MD

V

Vu NA Ho, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure.

M J Harmsen, T Van den Bosch, R A de Leeuw...

https://pubmed.ncbi.nlm.nih.gov/34587658