NCT06372119 Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)
| NCT ID | NCT06372119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mỹ Đức Hospital |
| Condition | Embryo Transfer |
| Study Type | INTERVENTIONAL |
| Enrollment | 790 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2026-04 |
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 790 participants in total. It began in 2024-04-22 with a primary completion date of 2026-04.
⚠ 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
The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is: • Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation? Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe letrozole 5 milligrams/day for 5 days to stimulate follicular development and micronized progesterone 800 milligrams/day for luteal phase support. In contrast, the AC group will receive oral estradiol valerate 6-12 milligrams/day and micronized progesterone 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates.
Eligibility Criteria
Inclusion Criteria: * Aged between 18 - 42. * Irregular menstrual cycle (\< 21 days or \> 35 days or \< 8 cycles/years). * Indicated for endometrial preparation. * Transfer of only one blastocyst. * Not participating in any other trials. Exclusion Criteria: * Allergy to letrozole or Ovitrelle or oral estradiol valerate or micronized progesterone * Having embryos from either oocyte donation or PGT (pre-implantation genetics testings) cycles. * Ovarian cysts that are unrelated to the oocyte pick-up. * Confirmed diagnosis with recurrent pregnancy loss (RPL) according to ESHRE guideline 2023, recurrent implantation failure (RIF) according to ESHRE 2023 good practice recommendations. * Endometrial abnormalities include endometrial hyperplasia, intrauterine adhesions, endometrial polyp, and chronic endometritis. * Uterine abnormalities include leiomyomas L0, L1, or L2 (according to FIGO 2011); adenomyosis (according to MUSA 2022); congenital uterine abnormalities, include didelphus, arcuate, unicornuate, bicornuate, septate (according to ASRM 2021). * Untreated hydrosalpinx.
Contact & Investigator
Lan TN Vuong, Assoc. Prof.
PRINCIPAL INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Frequently Asked Questions
Who can join the NCT06372119 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Embryo Transfer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06372119 currently recruiting?
Yes, NCT06372119 is actively recruiting participants. Contact the research team at bsnam.nt@myduchospital.vn for enrollment information.
Where is the NCT06372119 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06372119 clinical trial?
NCT06372119 is sponsored by Mỹ Đức Hospital. The principal investigator is Lan TN Vuong, Assoc. Prof. at University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 790 participants.