Clinical trial NCT06006091: The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Letrozole
Infertility, Female
Keywords: Frozen-thawed embryo transfer
Letroziole
Endothelial preparation protocol
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 858
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Live birth
timeFrame: 40-42 weeks'estimated gestational age
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 5-7 weeks' estimated gestational age
measure: embryo implantation
timeFrame: 14 day after embryo transfer
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yu Xiao
Study officials:
References: