Comparing letrozole and artificial cycles for preparing the uterus in women with irregular periods

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a letrozole-stimulated cycle strategy versus an artificial cycle strategy for endometrial preparation in women experiencing irregular menstrual cycles. Participants will be randomly assigned to receive either letrozole to stimulate follicular development or an artificial cycle regimen using estradiol and progesterone. The primary goal is to determine if the letrozole approach leads to a higher live birth rate after frozen embryo transfer compared to the artificial cycle method. The study addresses a significant challenge in assisted reproduction technology by exploring a more natural preparation method for the endometrium.

Why it matters

Who can join: the full rules

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.

Where it's running

• My Duc Hospital
  Ho Chi Minh City, Ho Chi Minh City, Vietnam Recruiting
• My Duc Phu Nhuan Hospital
  Ho Chi Minh City, Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Principal investigator: Lan TN Vuong, Assoc. Prof. — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Nam T Nguyen, MD.
• Email: bsnam.nt@myduchospital.vn
• Phone: +84354120209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.