Liraglutide and metformin
DrugLiraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
NCT Number: NCT06742710
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.
Interested in participating?
Request Info20 year–40 year
Female
Interventional
Phase 4
Peking University Third Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Metformin 1500 mg/day until pregnancy
Time frame: At delivery
The rate of live birth of intervention and control groups
Time frame: Thirty days after the embryo transplantation
Viable intrauterine pregnancy confirmed by ultrasound
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。
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).
Time frame: At delivery
Birth weight percentile for gestational age for neonatal sex
Time frame: At delivery
Apgar scores (0~10) of the newborns at delivery
Time frame: At delivery
Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.
Time frame: At delivery
Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study
Time frame: At month 6
Accumulated clinical pregnancy rate achieved during the first 6 months of the study
Time frame: At baseline, and week 12
Measured by the same weight scale
Time frame: At baseline, week 12, 28 weeks of pregnant, six weeks after delivery
oral glucose tolerance test was conducted to test glucose metabolism
Time frame: At baseline and week12
Glycosylated hemoglobin
Time frame: Throughout pregnancy
Time frame: From to 12 weeks
Time frame: At baseline, week 12
Free testosterone index
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.
Time frame: Baseline and week 12
Measured by Generalized Anxiety Disorder-7 scores, from 0 (no anxiety) to 21 (severe anxiety)
Time frame: Baseline and week 12
Measured by Patient Health Questionnaire-9 score from 0 (no depression) to 27 (severe depression)
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)
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
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.
Contact information is provided by the study sponsor or research team.
Haining Wang, Professor
CONTACT
Ye Liu, Associate Professor
CONTACT
Peking University Third Hospital
Other
Acronym: LITOP
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.
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