Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome

Conditions
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PCOS, Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: Acarbose 100 MG
* Drug: Exenatide
* Drug: Orlistat
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance | Drug: Metformin<br>* metformin effective subjects,act as control group<br>* Other names: METF;|
| Experimental: acarbose<br>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<br>* for metformin uneffective subjects, using acarbose for 3 months<br>* Other names: Acarbose;|
| Experimental: Exenatide<br>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<br>* for metformin uneffective subjects, using Exenatide for 3 months<br>|
| Experimental: Orlistat<br>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<br>* for metformin uneffective subjects, using Orlistatfor 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pregnant rate after intensive metabolic intervention | 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 | To compare the obsorbtion rate of four groups after treatment | up to 24 weeks | 
| Improvement of stillborn foetus rate after intensive metabolic intervention | To compare the stillborn foetus rate of four groups after treatment | up to 24 weeks | 
| Improvement of hyperandrogenism | 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 | To compare the intravenous blood glucose of three groups after treatment | up to 24 weeks | 
| Improvement of triglyceride | To compare the circulating triglyceride of three groups after treatment | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, imparied glucose tolerance