Research of Intensive Metabolic Intervention Before Pregnancy in PCOS

Impaired Glucose Tolerance Clinical Trial

— PCOS  

Official title:

Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03383068
• Other study ID #: [2017]055
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 28, 2017
• Last updated: December 21, 2017
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2017
• Source: RenJi Hospital
• Contact: Tao Tao, MD
• Phone: 86-13817701776
• Email: taotaosh76[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• PCOS

Intervention

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

Locations

Country	Name	City	State
China	Renji Hospital Department of Endocrinology and Metabolism	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pregnant rate after intensive metabolic intervention	To compare the pregnant rate of four groups after treatment	up to 24 weeks
Secondary	Improvement of obsorbtion rate after intensive metabolic intervention	To compare the obsorbtion rate of four groups after treatment	up to 24 weeks
Secondary	Improvement of stillborn foetus rate after intensive metabolic intervention	To compare the stillborn foetus rate of four groups after treatment	up to 24 weeks
Secondary	Improvement of hyperandrogenism	To compare the free androgen index of three groups after treatment	up to 24 weeks
Secondary	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
Secondary	Improvement of triglyceride	To compare the circulating triglyceride of three groups after treatment	up to 24 weeks