Research of Intensive Metabolic Intervention Before Pregnancy in PCOS (PCOS)

December 21, 2017 updated by: RenJi Hospital

Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 with IGR / DM not effective of metformin treatment 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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital Department of Endocrinology and Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
Drug: Metformin
metformin effective subjects,act as control group
Other Names:
  • METF
Experimental: acarbose
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months
Drug: Acarbose 100 MG
for metformin uneffective subjects, using acarbose for 3 months
Other Names:
  • Acarbose
Experimental: Exenatide
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months
Drug: Exenatide
for metformin uneffective subjects, using Exenatide for 3 months
Experimental: Orlistat
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months
Drug: Orlistat
for metformin uneffective subjects, using Orlistatfor 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of pregnant rate after intensive metabolic intervention
Time Frame: up to 24 weeks
To compare the pregnant rate of four groups after treatment
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of obsorbtion rate after intensive metabolic intervention
Time Frame: up to 24 weeks
To compare the obsorbtion rate of four groups after treatment
up to 24 weeks
Improvement of stillborn foetus rate after intensive metabolic intervention
Time Frame: up to 24 weeks
To compare the stillborn foetus rate of four groups after treatment
up to 24 weeks
Improvement of hyperandrogenism
Time Frame: up to 24 weeks
To compare the free androgen index of three groups after treatment
up to 24 weeks
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
Time Frame: up to 24 weeks
To compare the intravenous blood glucose of three groups after treatment
up to 24 weeks
Improvement of triglyceride
Time Frame: up to 24 weeks
To compare the circulating triglyceride of three groups after treatment
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Tao Tao, MD, Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2017]055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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