NCT06006091 The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
| NCT ID | NCT06006091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Peace Maternity and Child Health Hospital |
| Condition | Letrozole |
| Study Type | INTERVENTIONAL |
| Enrollment | 858 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 858 participants in total. It began in 2023-08-01 with a primary completion date of 2026-08-01.
⚠ 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 single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. The main questions it aims to answer are: * To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate. * To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic. The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (\<25 d or \>35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06006091 clinical trial?
This trial is open to female participants only, up to 40 Years, studying Letrozole. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06006091 currently recruiting?
Yes, NCT06006091 is actively recruiting participants. Contact the research team at chengliang_zhou@163.com for enrollment information.
Where is the NCT06006091 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06006091 clinical trial?
NCT06006091 is sponsored by International Peace Maternity and Child Health Hospital. The trial plans to enroll 858 participants.