E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women with endometriosis who have been diagnosed with Stages III -IV according to rASRM criteria
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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 |
Objective of the trial is to find out, whether women with Stage III-IV rASRM endometriosis benefit from the therapy with leuporelinacetat prior to IVF - therapy.
Primary endpoint of the study is the pregnancy rate in the 3 study groups. |
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E.2.2 | Secondary objectives of the trial |
Number of follicles on day 2-3 17-beta-Estradiol [pg/ml] FSH on day 2-3 days until hCG is given thickness of endometrial layer when hCG is given [mm] number of pre-ovulatory follicles bigger than 14 mm when hCG is given 17-beta-Estradiol [pg/ml] when hCG is given 17-beta-Estradiol / follicle > 14 mm [pg/ml] oocyte retrieval possible[ja/nein] number of oocytes quality of oocytes (maturity) (Ordinalscale of 4 qualities) fertilisation rate [ordinalscale with 4 degrees] number of kryoconserved Embryos quality of embryos– grade of blastomeres [ordinalscale with 3 degrees] quality of embryos – number of fragments [ordinalscale with 4 degrees] quality of embryos – cleavage rate 48 h after Insemination [ordinalscale with 4 degrees] embryotransfer [yes/no] embryotransfers [0,1,2,3] multiple pregnancies [2,3] number of abortions before 12. week o gestation rate of ectopic pregnancies birth – at term [yes/no] elective caesarian section [yes/no] number of malformations
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
women of age 18-40 with diagnosis of endometriosis stages III-IV according to rASRM criteria who had surgery during the last 3 month before beeing recruites to the study
FSH<12 IU/ml
signed informed consent
negative pregnancy test |
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E.4 | Principal exclusion criteria |
pregnancy and lactation
all contraindications against tested medication all possible interaction (e.g. allergies) with tested medication participation in other clinical trial parallel or 8 weeks prior to this study
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | 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 |
No drug therapy, only surgery |
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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 | 8 |
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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all provided in the protocol |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |