E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042391 |
E.1.2 | Term | Subfertility |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042392 |
E.1.2 | Term | Subfertility (female) |
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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 |
Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins |
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E.2.2 | Secondary objectives of the trial |
Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher live birth rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women: Normo-ovulatory ( cycles: 26-32d), age<43, BMI≤30. Presence of at least one patent tube on hysterosalpingography and/or laparoscopy, normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)
Men: Sperm sample with a total motile count ≥ 5 Miljon/ml after capacitation
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E.4 | Principal exclusion criteria |
Patients with a contra indication for the use of crinone : Known hypersensitivity to progesterone or one of the components of Crinone, vaginal bleeding of unknown origin, known or suspected malignancy of the breast or the reproductive system, acute porphyria, meningioma, patients with a history of or experiencing thrombophlebitis, trombo-embolic disease or cerebrovascular accident, non-ongoing pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical pregnancy rate per IUI cycle: positive ultrasound with gestational sac and at least one fetal heart beat detected by ultrasound at ± 5 to 6 weeks after IUI |
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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 | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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 | No |
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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Last visit of last subject undergoing the trial, estimated to be in December 2012 |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |