E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polycystic Ovary Syndrome |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Outcome Measure: Live birth rate per frozen embryo replacement treatment cycle |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Outcome Measure: Live birth rate per frozen embryo replacement treatment cycle
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Treatment arm without adujuvant metformin co-treatment |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial defined as the final visit made by the last subject as part of their treatment cycle. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |