The effect of metformin co-treatment in hormone-replacement frozen embryo replacement cycles in women with polycystic ovary syndrome. - Metformin in frozen embryo replacement cycles in women with PCOS

• Conditions: Polycystic Ovary Syndrome

• Registration Number: EUCTR2009-017245-64-GB
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-10
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Women who will be invited to take part in this study would be subject to following inclusion criteria:
•Women with a known diagnosis of PCOS (as defined by the Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group, 2004)
•Women must have cryopreserved embryos created with their own oocytes and be embarking upon their 1st FERC using this cohort of embryos
•Women must have a normal follicular stimulating hormone (FSH) level, (ref. range 1-8.0iU/L)
•Women must be 20-39 years of age
•Women must have a BMI<35
•Pre-treatment inclusion criteria would include:
oSerum testosterone level (< 5.0 nmol/l)
oNormal prolactin level (ref. range <600mU/L)
oNormal thyroid function test level (TSH ref. range 0.2-6.0 mIU/L)
oNormal renal, liver & haematological indices

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women who do not conform to the above criteria would be excluded from the study

In addition to the above these specific exclusion criteria would apply:
•Women who have had three or more failed IVF-ET cycles.
•Women who in previous frozen embryo replacement cycles have demonstrated insufficient endometrial thickening with standard treatment doses of Progynova.
•Women on other oral-antidiabetic agents or blood-glucose lowering preparations.
•Women taking phenprocoumon
•Women taking antivirals such as didanosine, stavudine, tenofovir.
•Women taking cimetidine
•Women taking ketofen
•Women who have radiological examinations using contrast media within the preceding 48 hours.
•Women with renal or hepatic impairment
•Women who have had a recent myocardial infarct
•Women with known vitamin B12 deficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified