Polycystic Ovary Syndrome
Conditions
Interventions
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Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Outcome Measure: Live birth rate per frozen embryo replacement treatment cycle;Secondary Objective: Secondary Outcome Measures: •Ultrasound based measures: Endometrial thickness on day of embryo transfer Endometrial echogenicity on day of embryo transfer Triple stripe appearance of endometrium on day of embryo transfer Detection rate of subendometrial blood flow on day of embryo transfer Subendometrial blood flow on the day of embryo transfer Uterine artery blood flow day of embryo transfer •Biochemistry based measures: Serum Glycodelin concentration on day of embryo transfer Serum IGFBP-1 concentration on day of embryo transfer •Pregnancy based measures: Biochemical pregnancy rate (Positive serum hCG)per frozen embryo replacement treatment cycle Clinical pregnancy rate (Pregnancy demonstrable on USS)per frozen embryo replacement treatment cycle Miscarriage rate per frozen embryo replacement treatment cycle ;Primary end point(s): Primary Outcome Measure: Live birth rate per frozen embryo replacement treatment cycle | — |
Countries
United Kingdom
Outcome results
None listed