Effects of GLP-1RAs on Fertility Outcomes in Obese Women With PCOS

NCT07687667 — Not applicable, Not yet recruiting, 406 participants, Peking University Third Hospital

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Effects of GLP-1 Receptor Agonists Combined With Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Obese Women With Polycystic Ovary Syndrome

Registry	NCT07687667
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	406 (Estimated)
Sponsor	Peking University Third Hospital (Other)
Conditions	Polycystic Ovary Syndrome (PCOS), Obesity, Infertility, Female
Interventions	GLP-1 receptor agonist, Metformin (Drug)
Dates	start 2026-07-01 (estimated), primary completion 2028-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2026-07-07, last updated 2026-07-07
Locations	1 site in China

-Summary

The goal of this clinical trial is to examine whether GLP1-RA and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental: GLP-1 RAs combined with healthy lifestyle education	Experimental	Drug: GLP-1 receptor agonist	Benaglutide injection (Fisuomei®, National Medicine Standard No. S20230042, Shanghai Renhui Biopharmaceutical Co., Ltd.) was administered at an initial dose of 0.06 mg per injection, three times daily, via subcutaneous injection 5 minutes before meals. After establishing tolerance, the dose was increased weekly by 0.04 mg per injection, reaching 0.2 mg per injection after four weeks, administered three times daily for a total of 12 weeks.Assisted reproductive treatment was initiated upon completion of the 12-week intervention.
metformin and healthy lifestyle education	Active comparator	Drug: Metformin	Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was administered at a dose of 0.5 g twice daily for 12 weeks, taken with meals. Assisted reproductive treatment was initiated upon completion of the 12-week intervention.

GLP-1 receptor agonist (Drug): 12 weeks treatment
Metformin (Drug): 12 weeks treatment

+Outcome measures

Primary outcomes

Ongoing Pregnancy Rate [First cycle of IVF/ICSI-ET (the first frozen-thawed embryo transfer cycle if all embryos are cryopreserved after oocyte retrieval)]: Ongoing Pregnancy Rate (OPR) The percentage of embryo transfer cycles with an intrauterine pregnancy sustained beyond 20 gestational weeks, with a gestational sac and fetal cardiac activity confirmed via transvaginal ultrasound, out of all embryo transfer cycles.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

Inclusion Criteria:

* Women with a wish to conceive;
* Women with PCOS (Rotterdam criteria);
* 28 kg/m2≤BMI<35kg/m2;
* Age: 18-40 years old

Exclusion Criteria:

* Women with diseases unsuitable for pregnancy or any other contraindications to infertility treatment Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine abnormalities that may affect assisted reproductive outcomes, untreated hydrosalpinx Male azoospermia, severe oligozoospermia and asthenospermia, or patients receiving donor sperm treatment Chromosomal abnormalities, patients planning preimplantation genetic testing (PGT) or donor oocyte treatment History of recurrent miscarriag Allergic to or contraindicated for GLP-1 class medications.

+Locations (1)

Facility	City	Country	Status
Peking University Third Hospital	Beijing, Beijing Municipality	China