Liraglutide Treatment in Obese Infertile PCOS Women

Short name LITOP

NCTNCT06742710Other idLITOP

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 890 participants (estimated)
Sponsor: Peking University Third Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 22 May 2025
Primary completion: 30 May 2029 (estimated)
Completion: 31 Dec 2029 (estimated)
First posted: 19 Dec 2024
Last update posted: 29 May 2025
Conditions: PCOS · Obesity · Infertility

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027202820292030

Ph 4
LITOP
NCT06742710
22 May 2025 to est. 31 Dec 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Liraglutide and metforminDrug
MetforminDrug

Arms2

Experimental
Intervention Group
Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day
Active comparator
Control Group
Metformin 1500 mg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

Live birth rate associated with single cycle frozen embryo transfer
Time frame · At delivery
Registry description
The rate of live birth of intervention and control groups

Secondary outcomes(8)

Clinical pregnancy rate of single cycle frozen embryo transfer
Time frame · Thirty days after the embryo transplantation
Registry description
Viable intrauterine pregnancy confirmed by ultrasound
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Time frame · At 28 weeks of pregnancy
Registry description
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
Registry description
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
Registry description
Birth weight percentile for gestational age for neonatal sex
Apgar scores
Time frame · At delivery
Registry description
Apgar scores (0\~10) of the newborns at delivery
Other perinatal outcomes
Time frame · At delivery
Registry description
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
Registry description
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
Registry description
Accumulated clinical pregnancy rate achieved during the first 6 months of the study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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;

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