Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Metformin
- Conditions
- PCOS
- Sponsor
- RenJi Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Improvement of pregnant rate after intensive metabolic intervention
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
control
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
Intervention: Metformin
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
Intervention: Acarbose 100 MG
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
Intervention: Exenatide
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
Intervention: Orlistat
Outcomes
Primary Outcomes
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 Outcomes
- Improvement of stillborn foetus rate after intensive metabolic intervention(up to 24 weeks)
- Improvement of obsorbtion rate after intensive metabolic intervention(up to 24 weeks)
- Improvement of hyperandrogenism(up to 24 weeks)
- Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation(up to 24 weeks)
- Improvement of triglyceride(up to 24 weeks)