Clinical trial NCT03383068: Research of Intensive Metabolic Intervention Before Pregnancy in PCOS
Official title: Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PCOS
Impaired Glucose Tolerance
Keywords: PCOS
imparied glucose tolerance
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of pregnant rate after intensive metabolic intervention
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Improvement of obsorbtion rate after intensive metabolic intervention
timeFrame: up to 24 weeks
measure: Improvement of stillborn foetus rate after intensive metabolic intervention
timeFrame: up to 24 weeks
measure: Improvement of hyperandrogenism
timeFrame: up to 24 weeks
measure: Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation
timeFrame: up to 24 weeks
measure: Improvement of triglyceride
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Department of Endocrinology and Metabolism
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Tao Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: