About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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;
patients who underwent pre-implantation genetic diagnosis (PGT);
patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2;
Trial design
Parallel
Treatments tested in this trial
Letrozole
DrugDifferent endothelial preparations according to groups, see arm descriptions for details
Treatment groups
Trial outcomes
Primary outcomes
Live birth
The number of deliveries resulting in at least one live birth
Secondary outcomes
Clinical pregnancy
Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
embryo implantation
Serum Human Chorionic Gonadotropin levels \>10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred
Sponsors and contacts
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