Overview

Study to Assess the Effect of Metformin Supplementation on IVF Outcome in Patients With Polycystic Ovarian Syndrome.

Status:
Completed
Trial end date:
2015-07-23
Target enrollment:
0
Participant gender:
Female
Summary
This study was performed to investigate the effects of metformin on controlled ovarian stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison of serum and follicular fluid cytokines and hormones in patients with polycystic ovary syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist protocol.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chung-Hoon Kim
Treatments:
Metformin
Criteria
Inclusion Criteria:

- PCOS diagnostic criteria

- 2003 American Society for Reproductive Medicine(ARSM)/European Society of Human
Reproduction and Embryology(ESHRE) consensus meeting guideline

- include two out of three

1. Oligo - or anovulation

2. Clinical or/and biochemical hyperandrogenism

3. Polycystic ovaries on ultrasound, exclusion of other etiologies( ≥ 12
follicles(2-9 mm diameter) in each ovary or ovarian volume(0.5 x length x
width x thickness) ≥ 10cm3)

- Anatomical normal uterus

- Normal level of thyroid hormone

Exclusion Criteria:

- Severe endometriosis(stageIII, IV)

- Endometrial thickness less than 7mm in late follicular phase

- Severe male infertility factor, non-obstructive azoospermia

- History of ectopic pregnancy or abortion over the last 3 months

- Unexplained abnormal uterine bleeding

- Congenital adrenal hyperplasia

- Androgen secreting tumor

- Cushing syndrome

- Concurrent administration of metformin, ovulation induction drugs, oral contraceptives
within previous 3 months

- Chronic disease(liver, kidney, severe heart failure, DM)

- Any pathology of genital tract

- History of alcohol abuse

- Refuse of study participate consent