Study Results
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Basic Information
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RECRUITING
PHASE4
890 participants
INTERVENTIONAL
2025-05-22
2029-12-31
Brief Summary
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Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day
Liraglutide and metformin
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Control Group
Metformin 1500 mg/day
Metformin
Metformin 1500 mg/day until pregnancy
Interventions
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Liraglutide and metformin
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Metformin
Metformin 1500 mg/day until pregnancy
Eligibility Criteria
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Inclusion Criteria
* Aged 20-40 years;
* 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
* Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;
* Have at least 1 transplantable frozen embryo available at the research center;
* Able to follow the study's contraceptive requirements.
Exclusion Criteria
* HbA1c ≥ 9.0% before enrollment;
* Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
* Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
* 17 hydroxyprogesterone in follicualr phase \> 2.0 ng/ml;
* Serious cardiovascular, digestive, liver, or kidney diseases, HBsAg-positive chronic hepatitis B, active pulmonary tuberculosis, or AIDS, etc. that are infectious or hereditary diseases;
* Any psychiatric or psychological disorders requiring drug treatment;
* Poor pregnancy and delivery history: recurrent failed implantations ≥3 times, spontaneous abortions ≥2 times; history of stillbirth, dystocia, or birth defects; previous pregnancies with preeclampsia, eclampsia, or HELLP syndrome;
* Uncontrolled metabolic, autoimmune, or hereditary disease in the husband;
* A contraindication or relative contraindication to using GLP-1 receptor agonists (history of medullary thyroid carcinoma or family history of medullary thyroid carcinoma, acute cholecystitis or pancreatitis in the acute phase or history of previous attacks, GLP-1 receptor agonist allergy, etc.);
* Failure to comply with the contraceptive requirements of the study design;
* Failure to take medication regularly and follow up;
* Current smokers, drug addicts, alcoholics, or individuals with substance abuse;
* Participants who have participated in any clinical trial within the past 3 months prior to screening;
* Individuals with other conditions deemed unsuitable for participation in this clinical trial by the investigator;
20 Years
40 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Obstetrics and Gynecology Hospital
Beijing, , China
Haidian District Maternal and Child Health Care Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Prof. Liu
Role: primary
Other Identifiers
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LITOP
Identifier Type: -
Identifier Source: org_study_id
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