LivingGLP1
Study S001012

Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study

ClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT05702905
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE4
Masking
NONE
Status
UNKNOWN
Enrollment
75
Start
2023-05-09
Primary completion
2024-12-31
Lead sponsor
Peking University First Hospital
Conditions
PCOS (Polycystic Ovary Syndrome); Semaglutide
Interventions
DRUG:Metformin Hydrochloride 500 MG; DRUG:Semaglutide, 1.34 mg/mL; DRUG:Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG; BEHAVIORAL:calorie-restricted diet; BEHAVIORAL:physical exercise
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Percentage change in bodyweight at 12 weeks for semaglutide versus metformin [at the end of 12 weeks of treatment]
  • Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin [at the end of 12 weeks of treatment]

Linked records (11)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0013131GLP-1 receptor agonists, polycystic ovary syndrome and reproductive dysfunction: Current research and future horizons.
Papaetis GS, Advances in clinical and experimental medicine : official organ Wroclaw Medical University
2022Narrative reviewPMID 35951627DOIregistry reference RESULT:35951627
R0022033Effect of metformin and exenatide on pregnancy rate and pregnancy outcomes in overweight or obese infertility PCOS women: long-term follow-up of an RCT.
Li R, Archives of gynecology and obstetrics
2022Randomized trialPMID 35829765DOIregistry reference RESULT:35829765
R0022789The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis.
Ge JJ, Journal of endocrinological investigation
2022Systematic reviewPMID 34455568DOIregistry reference RESULT:34455568
R0025102Effect of metformin versus metformin plus liraglutide on gonadal and metabolic profiles in overweight patients with polycystic ovary syndrome.
Xing C, Frontiers in endocrinology
2022Randomized trialPMID 36060969DOIregistry reference RESULT:36060969
R0011463Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome.
Ma RL, Chinese medical journal
2021Randomized trialPMID 34732660DOIregistry reference RESULT:34732660
R0012933Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists.
Cena H, The Journal of clinical endocrinology and metabolism
2020Narrative reviewPMID 32442310DOIregistry reference RESULT:32442310
R0016841GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis.
Han Y, Reproductive biomedicine online
2019Systematic reviewPMID 31229399DOIregistry reference RESULT:31229399
R0025861Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study.
Salamun V, European journal of endocrinology
2018Randomized trialPMID 29703793DOIregistry reference RESULT:29703793
R0027033Efficacy of exenatide on weight loss, metabolic parameters and pregnancy in overweight/obese polycystic ovary syndrome.
Liu X, Clinical endocrinology
2017Randomized trialPMID 28834553DOIregistry reference RESULT:28834553
R0013159A 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.
Jensterle M, Hormones (Athens, Greece)
2015Randomized trialPMID 25885106DOIregistry reference RESULT:25885106
R0018103Short-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.
Jensterle Sever M, European journal of endocrinology
2014Randomized trialPMID 24362411DOIregistry reference RESULT:24362411