The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

Not Applicable

Recruiting

• Conditions: Letrozole; Infertility, Female
• Interventions: Drug: Letrozole

• Registration Number: NCT06006091
• Lead Sponsor: International Peace Maternity and Child Health Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted QC: 2023-08-16
• Last Update Submitted: 2023-08-16
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 858

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole-induced endometrial preparation protocol	Letrozole	Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer.

Primary Outcome Measures

Name	Time	Method
Live birth	40-42 weeks'estimated gestational age	The number of deliveries resulting in at least one live birth

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	5-7 weeks' estimated gestational age	Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
embryo implantation	14 day after embryo transfer	Serum Human Chorionic Gonadotropin levels \>10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred

Trial Locations

Locations (1)

Yu Xiao; 🇨🇳 Shanghai, China