The use of Metformin and Gonadotrophin Releasing Hormone Antagonist for the treatment of women with Polycystic Ovary Syndrome undergoing In-vitro Fertilisation-Embryo Transfer. - Metformin and GnRH Antagonist co-treatment in IVF for women with PCOS
- Conditions
- Polycystic ovary syndrome.
- Registration Number
- EUCTR2009-010952-81-GB
- Lead Sponsor
- eeds Teaching Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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 a normal follicular stimulating hormone (FSH) •Women must be 20-39 years of age •Women must have a BMI = 35 •Pre-treatment inclusion criteria would include: oSerum testosterone < 5.0 nmol/l oNormal prolactin oNormal thyroid function tests oNormal renal, liver & haematological indices
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method