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Not yet recruitingNCT07687667Updated Jul 7, 2026

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

An interventional study of GLP-1 receptor agonist and Metformin in Polycystic Ovary Syndrome (PCOS), Obesity and Infertility, Female, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome (PCOS)
  • Obesity
  • Infertility, Female
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.

This study's planned enrollment of 406 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
406 participants (estimated)

Study arms

  • Experimental
    Experimental: GLP-1 RAs combined with healthy lifestyle education

    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.

    Drug: GLP-1 receptor agonist

  • Active comparator
    metformin and healthy lifestyle education

    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.

    Drug: Metformin

Interventions

  • DrugGLP-1 receptor agonist

    12 weeks treatment

  • DrugMetformin

    12 weeks treatment

06

What researchers measure

Primary outcomes

  1. Ongoing Pregnancy Rate

    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.

    Time frame: First cycle of IVF/ICSI-ET (the first frozen-thawed embryo transfer cycle if all embryos are cryopreserved after oocyte retrieval)

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07687667
Lead sponsor
Peking University Third Hospital
Responsible party
Huangshuo (Associate Professor, Peking University Third Hospital) — Principal investigator
First posted
Jul 7, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jul 7, 2026

Study contacts

Shuo Huang
Contact
homelyleaf@aliyun.com
+861082266699

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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