PCOS

UnknownPhase 4

Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome

Lead sponsor

RenJi Hospital

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

160

Study population

PCOS, Prediabetes / glucose intolerance

Eligibility highlights

•Female

Primary endpoint

•Improvement of pregnant rate after intensive metabolic intervention

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 IDNCT03383068

Org study ID[2017]055

Timeline

Milestones

Study first posted2017-12-26actual

Last update posted2017-12-26actual

Study start2018-01-01estimated

Primary completion2018-12-31estimated

Study completion2020-06-30estimated

Assets

Investigational agents

Exenatide

Who this study enrolls

PCOSPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•PCOS women at Childbearing Age

•PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.

Exclusion criteria

•Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).

•History of current or past pregnancy

•Hormonal contraceptive or metformin use within 3 months of enrollment

•Nonclassical congenital adrenal hyperplasia

Endpoints (6)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation

Time frame:up to 24 weeks

categorical status, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Improvement of triglyceride

Time frame:up to 24 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Improvement of pregnant rate after intensive metabolic intervention

Time frame:up to 24 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Improvement of stillborn foetus rate after intensive metabolic intervention

Time frame:up to 24 weeks

event count, event

Secondary/protocol endpoint

Improvement of hyperandrogenism

Time frame:up to 24 weeks

Androgen, change

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Improvement of obsorbtion rate after intensive metabolic intervention

Time frame:up to 24 weeks

descriptive

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.