Clinical trial · Interventional
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
| Semaglutide | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calorie-restricted diet | Behavioral | — | UNRESOLVED |
| Metformin Hydrochloride 500 MG | Drug | Metformin | ALIAS |
| physical exercise | Behavioral | — | UNRESOLVED |
| Semaglutide, 1.34 mg/mL | Drug | — | UNRESOLVED |
| Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- metformin
- description
- About 25 subjects will be allocated to this group to receive metformin only, as the active comparator of semaglutide groups. Metformin used in this trial is Glucophage ( 500mg per tablet）produced by Bristol-Myers Squibb.The initial dose of metformin will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.
- interventionNames
- Drug: Metformin Hydrochloride 500 MG
- Behavioral: calorie-restricted diet
- Behavioral: physical exercise
- type
- EXPERIMENTAL
- label
- semaglutide
- description
- About 25 subjects will be allocated to this group to receive semaglutide only, as one of the experimental groups. Semaglutide used in this trial is WEGOVY (semaglutide) injection produced by Novo Nordisk. Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh or upper arm. Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 1.0 mg is reached, and then maintained 1.0 mg until the end of treatment in total 12 weeks..
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Meet the PCOS diagnostic criteria (Rotterdam） 2. Age 22-40 3. BMI ≥ 28 kg/m2 4. Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year 5. Willing to be pregnant, and her husband has no serious infertility Exclusion Criteria: 1. History of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas 2. Type 1 diabetes and special type diabetes 3. History of tumor 4. Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney disease 5. Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions were used within 90 days before the study 6. Known allergy to metformin, GLP-1 RA and excipients 7. Severe endometriosis, low ovarian reserve, premature ovarian failure 8. Inability to tolerate pregnancy and ovulation induction therapy 9. Other conditions considered unsuitable for this study by researchers
References
Publications (11)
- RESULTJensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar. PMID 24362411
- RESULTJensterle M, Kravos NA, Pfeifer M, Kocjan T, Janez A. A 12-week treatment with the long-acting glucagon-like peptide 1 receptor agonist liraglutide leads to significant weight loss in a subset of obese women with newly diagnosed polycystic ovary syndrome. Hormones (Athens). 2015 Jan-Mar;14(1):81-90. doi: 10.1007/BF03401383. PMID 25885106
- RESULTSalamun V, Jensterle M, Janez A, Vrtacnik Bokal E. Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study. Eur J Endocrinol. 2018 Jul;179(1):1-11. doi: 10.1530/EJE-18-0175. Epub 2018 Apr 27. PMID 29703793
- RESULTHan Y, Li Y, He B. GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis. Reprod Biomed Online. 2019 Aug;39(2):332-342. doi: 10.1016/j.rbmo.2019.04.017. Epub 2019 Apr 25. PMID 31229399
- RESULTCena H, Chiovato L, Nappi RE. Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2695-709. doi: 10.1210/clinem/dgaa285. PMID 32442310
- RESULTXing C, Zhao H, Zhang J, He B. Effect of metformin versus metformin plus liraglutide on gonadal and metabolic profiles in overweight patients with polycystic ovary syndrome. Front Endocrinol (Lausanne). 2022 Aug 17;13:945609. doi: 10.3389/fendo.2022.945609. eCollection 2022. PMID 36060969
- RESULTPapaetis GS, Kyriacou A. GLP-1 receptor agonists, polycystic ovary syndrome and reproductive dysfunction: Current research and future horizons. Adv Clin Exp Med. 2022 Nov;31(11):1265-1274. doi: 10.17219/acem/151695.