Letrozole preparation for frozen embryo transfer

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 858 (estimated)
• Ages: N/A to 40 Years
• Sex: Female
• Sponsor: International Peace Maternity and Child Health Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06006091 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

Why it matters

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

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

Eligibility 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 this trial is running

Shanghai

• Yu Xiao — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Chengliang Zhou, Dr.

Conditions: Letrozole, Infertility, Female, Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol