Current partner codePEPTIDESDE
NCT06742710·Phase 4·INTERVENTIONAL

Liraglutide Treatment in Obese Infertile PCOS Women

Status

Recruiting

Phase

Phase 4

Enrollment

890

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Liraglutide and metformin

Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.

DRUG

Metformin

Metformin 1500 mg/day until pregnancy

Timeline

From registration to results.

  1. First posted

    Dec 19, 2024

  2. Study start

    May 22, 2025

  3. Primary completion

    May 30, 2029

  4. Study completion

    Dec 31, 2029

  5. Results posted

    Not reported

  6. Registry updated

    May 29, 2025

Outcomes

What the study measures.

Primary outcomes

Live birth rate associated with single cycle frozen embryo transfer

Time frame · At delivery

The rate of live birth of intervention and control groups

Secondary outcomes

Clinical pregnancy rate of single cycle frozen embryo transfer

Time frame · Thirty days after the embryo transplantation

Viable intrauterine pregnancy confirmed by ultrasound

Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy

Time frame · At 28 weeks of pregnancy

Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。

Pregnancy outcome and complications

Time frame · From baseline to delivery

Rate of miscarriage, multiple pregnancies, pregnancy induced hypertension, preeclampsia, HELLP syndrome, prematurity (\< 37 weeks), macrosomia (birth weight \> 4 kg), induction of labour, prolonged duration of labour, caesarean section, assisted delivery, peripartum increased blood loss (≥ 800 ml).

Birth weight for gestational age

Time frame · At delivery

Birth weight percentile for gestational age for neonatal sex

Apgar scores

Time frame · At delivery

Apgar scores (0\~10) of the newborns at delivery

Other perinatal outcomes

Time frame · At delivery

Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.

Accumulated live birth rate

Time frame · At delivery

Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study

Accumulated clinical pregnancy rate

Time frame · At month 6

Accumulated clinical pregnancy rate achieved during the first 6 months of the study

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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;

Study locations

3 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.