Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Overview

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.

Full Title of Study: “Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • Drug: Acarbose 100 MG
    • for metformin uneffective subjects, using acarbose for 3 months
  • Drug: Exenatide
    • for metformin uneffective subjects, using Exenatide for 3 months
  • Drug: Orlistat
    • for metformin uneffective subjects, using Orlistatfor 3 months
  • Drug: Metformin
    • metformin effective subjects,act as control group

Arms, Groups and Cohorts

  • Other: control
    • metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Improvement of obsorbtion rate after intensive metabolic intervention
    • Time Frame: up to 24 weeks
    • To compare the obsorbtion rate of four groups after treatment
  • 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
  • Improvement of hyperandrogenism
    • Time Frame: up to 24 weeks
    • To compare the free androgen index of three groups after treatment
  • 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
  • Improvement of triglyceride
    • Time Frame: up to 24 weeks
    • To compare the circulating triglyceride of three groups after treatment

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tao Tao, MD, Principal Investigator, RenJi Hospital
  • Overall Contact(s)
    • Tao Tao, MD, 86-13817701776, taotaosh76@163.com

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