Clinical trial NCT06742710: Liraglutide Treatment in Obese Infertile PCOS Women
Official title: Liraglutide Treatment in Obese Infertile PCOS Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: PCOS
Obesity
Infertility
Keywords: polycystic ovary syndrome
liraglutide
infertile
obesity
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 890
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility.

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.


Eligibility criteria: Inclusion Criteria:

* Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic 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:

* Diabetic ketoacidosis or other acute complications of diabetes;
* 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;

Primary outcomes:
measure: Live birth rate associated with single cycle frozen embryo transfer
timeFrame: At delivery
Secondary outcomes:
measure: Clinical pregnancy rate of single cycle frozen embryo transfer
timeFrame: Thirty days after the embryo transplantation
measure: Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
timeFrame: At 28 weeks of pregnancy
measure: Pregnancy outcome and complications
timeFrame: From baseline to delivery
measure: Birth weight for gestational age
timeFrame: At delivery
measure: Apgar scores
timeFrame: At delivery
measure: Other perinatal outcomes
timeFrame: At delivery
measure: Accumulated live birth rate
timeFrame: At delivery
measure: Accumulated clinical pregnancy rate
timeFrame: At month 6
Other outcomes:
measure: Weight
timeFrame: At baseline, and week 12
measure: Oral glucose tolerance test
timeFrame: At baseline, week 12, 28 weeks of pregnant, six weeks after delivery
measure: HbA1c
timeFrame: At baseline and week12
measure: Rate of insulin usage during pregancy
timeFrame: Throughout pregnancy
measure: Number of menstrual cycles
timeFrame: From to 12 weeks
measure: Free testosterone index
timeFrame: At baseline, week 12
measure: Drug-related adverse reactions
timeFrame: During the treatment with liraglutide or metformin
measure: Anxiety
timeFrame: Baseline and week 12
measure: Depression
timeFrame: Baseline and week 12
measure: Quality of life specifically for PCOS individuals
timeFrame: Baseline and week 12
measure: Major congenital malformations
timeFrame: Six weeks after live birth
measure: Costs
timeFrame: At delivery
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital
city: Beijing
country: China
facility: Haidian District Maternal and Child Health Care Hospital
Study officials:
References: