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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06006091
Other study ID # InternationalPMCHH-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date August 1, 2027

Study information

Verified date August 2023
Source International Peace Maternity and Child Health Hospital
Contact Chengliang Zhou, Dr.
Phone 08613758240793
Email chengliang_zhou@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 858
Est. completion date August 1, 2027
Est. primary completion date August 1, 2026
Accepts healthy volunteers No
Gender Female
Age group N/A to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Letrozole
Different endothelial preparations according to groups, see arm descriptions for details

Locations

Country Name City State
China Yu Xiao Shanghai

Sponsors (1)

Lead Sponsor Collaborator
International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Live birth The number of deliveries resulting in at least one live birth 40-42 weeks'estimated gestational age
Secondary Clinical pregnancy Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles 5-7 weeks' estimated gestational age
Secondary embryo implantation Serum Human Chorionic Gonadotropin levels >10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred 14 day after embryo transfer
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