Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

RenJi Hospital160 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

PCOS Impaired Glucose Tolerance

Interventions

Acarbose 100 MGDRUG

for metformin uneffective subjects, using acarbose for 3 months

ExenatideDRUG

for metformin uneffective subjects, using Exenatide for 3 months

OrlistatDRUG

for metformin uneffective subjects, using Orlistatfor 3 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Improvement of pregnant rate after intensive metabolic intervention

To compare the pregnant rate of four groups after treatment

Time frame: up to 24 weeks

Secondary Outcomes

Improvement of obsorbtion rate after intensive metabolic intervention

To compare the obsorbtion rate of four groups after treatment

Time frame: up to 24 weeks

Improvement of stillborn foetus rate after intensive metabolic intervention

To compare the stillborn foetus rate of four groups after treatment

Time frame: up to 24 weeks

Improvement of hyperandrogenism

To compare the free androgen index of three groups after treatment

Time frame: up to 24 weeks

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

To compare the intravenous blood glucose of three groups after treatment

Time frame: up to 24 weeks

Improvement of triglyceride

To compare the circulating triglyceride of three groups after treatment

Time frame: up to 24 weeks

Central Contacts

Tao Tao, MD

CONTACT

86-13817701776 taotaosh76@163.com

Data from ClinicalTrials.gov

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