Liraglutide Treatment in Obese Infertile PCOS Women

NCT06742710 | Recruiting Phase 4 DMC

• 1 other identifier: LITOP
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 3

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.

Conditions

PCOS; Obesity; Infertility

Keywords

polycystic ovary syndrome; liraglutide; infertile; obesity

Outcome Measures

Primary Outcomes (1)

• Live birth rate associated with single cycle frozen embryo transfer

  The rate of live birth of intervention and control groups

  At delivery

Secondary Outcomes (8)

• Clinical pregnancy rate of single cycle frozen embryo transfer

  Thirty days after the embryo transplantation

• Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy

  At 28 weeks of pregnancy

• Pregnancy outcome and complications

  From baseline to delivery

• Birth weight for gestational age

  At delivery

• Apgar scores

  At delivery

Other Outcomes (12)

• Weight

  At baseline, and week 12

• Oral glucose tolerance test

  At baseline, week 12, 28 weeks of pregnant, six weeks after delivery

• HbA1c

  At baseline and week12

Study Arms (2)

Intervention Group

EXPERIMENTAL

Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day

Drug: Liraglutide and metformin

Control Group

ACTIVE COMPARATOR

Metformin 1500 mg/day

Drug: Metformin

Interventions

Liraglutide and metformin DRUG

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

Intervention Group

Metformin DRUG

Metformin 1500 mg/day until pregnancy

Control Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria.
• Aged 20-40 years;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (3)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Obstetrics and Gynecology Hospital

Beijing, China

NOT YET RECRUITING

Haidian District Maternal and Child Health Care Hospital

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Infertility; Polycystic Ovary Syndrome

Interventions

Liraglutide; Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Haining Wang, Professor

CONTACT

8601082265025; hainingmail@bjmu.edu.cn

Ye Liu, Associate Professor

CONTACT

8601082265025; yeliumed@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: December 19, 2024
• Study Start: May 22, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 29, 2025

Record last verified: 2024-12

Locations

CN (3)