Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06742710

Liraglutide Treatment in Obese Infertile PCOS Women

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Liraglutide and metformin

Drug

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

metformin

Drug

Metformin 1500 mg/day until pregnancy

Primary outcomes

  1. 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

  1. Clinical pregnancy rate of single cycle frozen embryo transfer

    Time frame: Thirty days after the embryo transplantation

    Viable intrauterine pregnancy confirmed by ultrasound

  2. 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。

  3. 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).

  4. Birth weight for gestational age

    Time frame: At delivery

    Birth weight percentile for gestational age for neonatal sex

  5. Apgar scores

    Time frame: At delivery

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

  6. Other perinatal outcomes

    Time frame: At delivery

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

  7. 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

  8. Accumulated clinical pregnancy rate

    Time frame: At month 6

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

Other outcomes

  1. Weight

    Time frame: At baseline, and week 12

    Measured by the same weight scale

  2. Oral glucose tolerance test

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

    oral glucose tolerance test was conducted to test glucose metabolism

  3. HbA1c

    Time frame: At baseline and week12

    Glycosylated hemoglobin

  4. Rate of insulin usage during pregancy

    Time frame: Throughout pregnancy

  5. Number of menstrual cycles

    Time frame: From to 12 weeks

  6. Free testosterone index

    Time frame: At baseline, week 12

    Free testosterone index

  7. Drug-related adverse reactions

    Time frame: During the treatment with liraglutide or metformin

    Drug-related adverse reactions, including but not limited to, nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation, drug allergy, hypoglycemia, acute pancreatitis, acute gallbladder disease.

  8. Anxiety

    Time frame: Baseline and week 12

    Measured by Generalized Anxiety Disorder-7 scores, from 0 (no anxiety) to 21 (severe anxiety)

  9. Depression

    Time frame: Baseline and week 12

    Measured by Patient Health Questionnaire-9 score from 0 (no depression) to 27 (severe depression)

  10. Quality of life specifically for PCOS individuals

    Time frame: Baseline and week 12

    Measured by Modified Polycystic ovary syndrome Quality of life, with each item scores from 1 (maximum impairment) to 7 (no impairment)

  11. Major congenital malformations

    Time frame: Six weeks after live birth

    Identified in the Birth Defects Prevention and Control Plan (2023-2027) issued by the National Health Commission of the People's Republic of China

  12. Costs

    Time frame: At delivery

    The cost per live birth for the different intervention groups, considering both direct medical and non-medical costs, as well as indirect costs.

Study contacts

Contact information is provided by the study sponsor or research team.

Haining Wang, Professor

CONTACT

[email protected]

8601082265025

Ye Liu, Associate Professor

CONTACT

[email protected]

8601082265025

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Acronym: LITOP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 19, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.