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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006091
• Other study ID #: InternationalPMCHH-1
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Letrozole

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