UnknownPhase 4

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

Lead sponsor

Peking University First Hospital

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, PCOS, Reproductive / infertility

Eligibility highlights

•BMI ≥28•Female

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05702905

Org study ID2022CR04

Timeline

Milestones

Study first posted2023-01-27actual

Study start2023-05-09actual

Last update posted2024-03-25actual

Primary completion2024-12-31estimated

Study completion2025-06-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightPCOSReproductive / infertility

Who can enroll

Minimum age22 Years

Maximum age40 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Primary/protocol endpoint

Percentage change in bodyweight at 12 weeks for semaglutide versus metformin

Time frame:at the end of 12 weeks of treatment

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin

Time frame:at the end of 12 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

HOMA-IR at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

HOMA-IR (insulin sensitivity)

descriptive, improvement

Patient-reported / QoL

4 endpoints

Other/protocol endpoint

Depression score by self-rating depression scale (SDS）at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

descriptive, improvement

Other/protocol endpoint

Anxiety score by self-rating anxiety scale (SAS）at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

change from baseline, improvement

Other/protocol endpoint

Diet score by TFEQ-18 (three factor eating questionaire) at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

descriptive

Other/protocol endpoint

Quality of life score at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

descriptive, improvement

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

testosterone level at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

androstenedione level at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

FAI (Free Androgen Index) at 12 weeks of treatment

Time frame:at the end of 12 weeks of treatment

Androgen, change

change from baseline, improvement

Other/protocol endpoint

Ovulation rate at 24 weeks of follow-up after the end of treatment

Time frame:at the end of 24 weeks of follow-up after the end of treatment

Ovulation rate

threshold achievement, improvement

Other/protocol endpoint

Clinical pregnancy rate at 24 weeks of follow-up after the end of treatment

Time frame:at the end of 24 weeks of follow-up after the end of treatment

threshold achievement, improvement

Other/protocol endpoint

Cumulative pregnancy rate at 24 weeks of follow-up after the end of treatment

Time frame:at the end of 24 weeks of follow-up after the end of treatment

threshold achievement, event

Publications (11)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

GLP-1 receptor agonists, polycystic ovary syndrome and reproductive dysfunction: Current research and future horizons.
Advances in clinical and experimental medicine : official organ Wroclaw Medical University2022 Nov (month)PMID35951627doi:10.17219/acem/151695via CT.gov reference
Effect of metformin and exenatide on pregnancy rate and pregnancy outcomes in overweight or obese infertility PCOS women: long-term follow-up of an RCT.
Archives of gynecology and obstetrics2022 Nov (month)PMID35829765doi:10.1007/s00404-022-06700-3via CT.gov reference
The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis.
Journal of endocrinological investigation2022 Feb (month)PMID34455568doi:10.1007/s40618-021-01666-6via CT.gov reference
Effect of metformin versus metformin plus liraglutide on gonadal and metabolic profiles in overweight patients with polycystic ovary syndrome.
Frontiers in endocrinology2022 (year)PMID36060969doi:10.3389/fendo.2022.945609via CT.gov reference
Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome.
Chinese medical journal2021 Nov 3PMID34732660doi:10.1097/CM9.0000000000001712via CT.gov reference
Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists.
The Journal of clinical endocrinology and metabolism2020 Aug 1PMID32442310doi:10.1210/clinem/dgaa285via CT.gov reference
GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis.
Reproductive biomedicine online2019 Aug (month)PMID31229399doi:10.1016/j.rbmo.2019.04.017via CT.gov reference
Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study.
European journal of endocrinology2018 Jul (month)PMID29703793doi:10.1530/EJE-18-0175via CT.gov reference
Efficacy of exenatide on weight loss, metabolic parameters and pregnancy in overweight/obese polycystic ovary syndrome.
Clinical endocrinology2017 Dec (month)PMID28834553doi:10.1111/cen.13454via CT.gov reference
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, Greece)2015 Jan-Mar (year)PMID25885106doi:10.1007/BF03401383via CT.gov reference
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.
European journal of endocrinology2014 Mar (month)PMID24362411doi:10.1530/EJE-13-0797via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.