Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day |
|
| Control Group | Active Comparator | Metformin 1500 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide and metformin | Drug | Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate associated with single cycle frozen embryo transfer | The rate of live birth of intervention and control groups | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate of single cycle frozen embryo transfer | Viable intrauterine pregnancy confirmed by ultrasound | Thirty days after the embryo transplantation |
| Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measured by the same weight scale | At baseline, and week 12 |
| Oral glucose tolerance test | oral glucose tolerance test was conducted to test glucose metabolism |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haining Wang, Professor | Contact | 8601082265025 | hainingmail@bjmu.edu.cn | |
| Ye Liu, Associate Professor | Contact | 8601082265025 | yeliumed@bjmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
De-identified individual participant data will be available if researchers provide a methodologically sound proposal and contact to the principal investigator. Data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007246 | Infertility |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin | Drug | Metformin 1500 mg/day until pregnancy |
|
Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。
| At 28 weeks of pregnancy |
| Pregnancy outcome and complications | 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). | From baseline to delivery |
| Birth weight for gestational age | Birth weight percentile for gestational age for neonatal sex | At delivery |
| Apgar scores | Apgar scores (0~10) of the newborns at delivery | At delivery |
| Other perinatal outcomes | Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit. | At delivery |
| Accumulated live birth rate | Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study | At delivery |
| Accumulated clinical pregnancy rate | Accumulated clinical pregnancy rate achieved during the first 6 months of the study | At month 6 |
| At baseline, week 12, 28 weeks of pregnant, six weeks after delivery |
| HbA1c | Glycosylated hemoglobin | At baseline and week12 |
| Rate of insulin usage during pregancy | Throughout pregnancy |
| Number of menstrual cycles | From to 12 weeks |
| Free testosterone index | Free testosterone index | At baseline, week 12 |
| Drug-related adverse reactions | Drug-related adverse reactions, including but not limited to, nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation, drug allergy, hypoglycemia, acute pancreatitis, acute gallbladder disease. | During the treatment with liraglutide or metformin |
| Anxiety | Measured by Generalized Anxiety Disorder-7 scores, from 0 (no anxiety) to 21 (severe anxiety) | Baseline and week 12 |
| Depression | Measured by Patient Health Questionnaire-9 score from 0 (no depression) to 27 (severe depression) | Baseline and week 12 |
| Quality of life specifically for PCOS individuals | Measured by Modified Polycystic ovary syndrome Quality of life, with each item scores from 1 (maximum impairment) to 7 (no impairment) | Baseline and week 12 |
| Major congenital malformations | Identified in the Birth Defects Prevention and Control Plan (2023-2027) issued by the National Health Commission of the People's Republic of China | Six weeks after live birth |
| Costs | The cost per live birth for the different intervention groups, considering both direct medical and non-medical costs, as well as indirect costs. | At delivery |
| Beijing Obstetrics and Gynecology Hospital | Not yet recruiting | Beijing | China |
|
| Haidian District Maternal and Child Health Care Hospital | Not yet recruiting | Beijing | China |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |