NCT07687667

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2029

First Submitted

Initial submission to the registry

June 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

June 24, 2026

Last Update Submit

July 1, 2026

Conditions

ObesityInfertility, FemalePolycystic Ovary Syndrome (PCOS)

Outcome Measures

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.

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

Study Arms (2)

Experimental: GLP-1 RAs combined with healthy lifestyle education

EXPERIMENTAL

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

metformin and healthy lifestyle education

ACTIVE COMPARATOR

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

GLP-1 receptor agonistDRUG

12 weeks treatment

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

12 weeks treatment

metformin and healthy lifestyle education

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeObesityInfertility, Female

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfertility

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Shuo Huang

CONTACT

+861082266699homelyleaf@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 7, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations

CN(1)