NCT06239376 Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients
| NCT ID | NCT06239376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mỹ Đức Hospital |
| Condition | Adenomyosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 222 participants in total. It began in 2024-02-19 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized clinical trial aims to assess the comparative effectiveness of two distinct endometrial preparation protocols for frozen embryo transfer (FET) among women with adenomyosis undergoing IVF/ICSI. Specifically, it seeks to address the following key questions: 1. Does the protocol involving the combination of GnRH agonist and letrozole for down regulation with exogenous steroids (GnRHa+AI - AC) result in a higher live birth rate compared to the use of exogenous steroids alone (AC) in women with adenomyosis undergoing frozen embryo transfer? 2. What are the common side effects of the GnRHa+AI - AC regimen? Eligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of two groups: GnRHa+AI - AC or AC. In the GnRHa+AI - AC group, participants will be pre-treated with GnRH agonist and letrozole two months before endometrial preparation. After this period, participants will return for endometrial preparation, and any side effects resulting from the down regulation will be evaluated. In contrast, the AC group will receive standard treatment.
Eligibility Criteria
Inclusion Criteria: * Confirm diagnosis with adenomyosis by using transvaginal ultrasonography (MUSA consensus) and/or pelvic magnetic resonance imaging. * Age between 18 - 42 * Undergo less or equal to three previous IVF cycles * Indicate for frozen embryo transfer * Agree to have not more than two day-3 embryo or one blastocyst (day-5 and day-6) transferred * Not participating in any other study Exclusion Criteria: * Embryos from IVM cycle * Having uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal leiomyoma, or leiomyoma with endometrial cavity distortion) * Having contraindications for exogenous hormones administration: breast cancer, risks of venous thromboembolism * Embryos from the oocyte donation cycle. * Patients with a history of GnRH injection within three months, measured from the last GnRHa injection to the study screening date.
Contact & Investigator
Lan N Vuong, MD, PhD
PRINCIPAL INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Frequently Asked Questions
Who can join the NCT06239376 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Adenomyosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06239376 currently recruiting?
Yes, NCT06239376 is actively recruiting participants. Contact the research team at bstien.lk@myduchospital.vn for enrollment information.
Where is the NCT06239376 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06239376 clinical trial?
NCT06239376 is sponsored by Mỹ Đức Hospital. The principal investigator is Lan N Vuong, MD, PhD at University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 222 participants.