Infertility, Female, Letrozole
Conditions
Keywords
Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol
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.
Interventions
DRUGLetrozole
Different endothelial preparations according to groups, see arm descriptions for details
Sponsors
International Peace Maternity and Child Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | 40-42 weeks'estimated gestational age | The number of deliveries resulting in at least one live birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactChengliang Zhou, Dr.
Backup ContactXiaojun Chen, Dr.
Outcome results
None listed