Clinical trial Recruiting at 1 site Interventional Ages Any age to 40 Women only

Letrozole preparation for frozen embryo transfer

Official title: Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study

Run by International Peace Maternity and Child Health Hospital · NCT06006091 · Data updated 2026-11-12

This study tests if using letrozole to prepare the uterus helps women have better pregnancy outcomes after frozen embryo transfers compared to other methods.

Quick facts

Study typeInterventional
AgesAny age to 40 Years
SexWomen only
Enrollment858 (estimated)
SponsorInternational Peace Maternity and Child Health Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedAugust 1, 2023
Main results expectedAugust 1, 2026
Study endsAugust 1, 2027
Registry record updatedAugust 23, 2023
Trial IDNCT06006091 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women under 40 years old who are undergoing IVF or ICSI with cryopreserved embryos.

Probably not a fit

Patients with certain reproductive health issues, such as severe endometriosis or chromosomal abnormalities, may not benefit from this study.

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 investigates the effectiveness of a letrozole-induced endometrial preparation protocol compared to natural cycles and hormone replacement protocols in women undergoing frozen-thawed embryo transfer (FET) after IVF or ICSI. The study aims to evaluate pregnancy outcomes, including live birth rates and clinical pregnancy rates, as well as other important indicators such as spontaneous abortion rates and the number of clinic visits required. Participants will be randomized based on their menstrual cycle regularity and will undergo specific treatment regimens starting from the early days of their cycle.

Why it matters

Potential benefit: If successful, this approach could improve pregnancy outcomes for women undergoing FET.

How similar studies have gone: While similar approaches have been explored, this specific protocol's effectiveness remains to be fully validated.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Women \<40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.

Exclusion Criteria:

1. Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
2. patients who underwent pre-implantation genetic diagnosis (PGT);
3. patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
4. patients with a Body mass index (BMI, = weight/height2 ) \> 30 kg/m2;
5. patients with recurrent spontaneous abortions;
6. patients with sequential embryo transfer.

Where it's running

  • Yu Xiao
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.