Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT)

Recruiting now · Not applicable

Conditions studied: Embryo Transfer, Irregular Menstruation, Letrozole, Hormone Replacement Therapy

In brief

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.

Key facts

Study ID

NCT06372119

Run by

Mỹ Đức Hospital

People needed

790

Starts

2024-04-22

Expected to finish

2026-04-01

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• My Duc Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (enrolling)
• My Duc Phu Nhuan Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.