Metformin and gonadotrophin-releasing hormone (GnRH) antagonist co-treatment in in-vitro fertilisation (IVF) for women with polycystic ovary syndrome (PCOS)

Phase 4

Completed

• Conditions: Polycystic ovary syndrome; Nutritional, Metabolic, Endocrine; Ovarian dysfunction

• Registration Number: ISRCTN21199799
• Lead Sponsor: eeds Teaching Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-25
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Women with a known diagnosis of PCOS (as defined by the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine [ESHRE/ASRM] sponsored PCOS consensus workshop group, 2004)
2. Women must have a normal serum follicular stimulating hormone (FSH) concentration (reference range 1 - 8.0 iU/L)
3. Women must be 20 - 39 years of age
4. Women must have a body mass index (BMI) less than or equal to 35 kg/m^2
5. Pre-treatment inclusion criteria to include:
5.1. Serum testosterone level less than 5.0 nmol/l
5.2. Normal prolactin level (reference range less than 600 mU/L)
5.3. Normal thyroid function test level (thyroid stimulating hormone [TSH] reference range 0.2 - 6.0 mIU/L)
5.4. Normal renal, liver and haematological indices

Exclusion Criteria

1. Women on other oral-antidiabetic agents or blood-glucose lowering preparations
2. Women taking phenprocoumon
3. Women taking antivirals such as didanosine, stavudine, tenofovir
4. Women taking cimetidine
5. Women taking ketofen
6. Women who have radiological examinations using contrast media within the preceding 48 hours
7. Women with renal or hepatic impairment
8. Women who have had a recent myocardial infarct
9. Women with known vitamin B12 deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified