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 | 2026-04-15 |
Trial Parameters
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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.