Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

NCT03383068 · Unknown status

Last updated 2026-05-28

This clinical trial tests whether an intensive metabolic intervention before pregnancy can improve pregnancy rates in women with polycystic ovary syndrome (PCOS) and impaired glucose tolerance.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 160 people Planned (estimated).

Who can join Ages 18–40 · female only

Timeline Started 2018-01 · est. completion 2020-06

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT03383068 ↗

Description as written by the study sponsor.

To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.

Treatments tested

Acarbose 100 MG also known as Acarbose Drug

for metformin uneffective subjects, using acarbose for 3 months
Exenatide Drug

for metformin uneffective subjects, using Exenatide for 3 months
Orlistat Drug

for metformin uneffective subjects, using Orlistatfor 3 months
Metformin also known as METF Drug

metformin effective subjects,act as control group

Main thing measured	Improvement of pregnant rate after intensive metabolic intervention
Sponsor	RenJi Hospital
Conditions studied	PCOS, Impaired Glucose Tolerance
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03383068 ↗