E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
(Sub)Fertility in endometriosis after laparoscopic removal of the endometriosos lesions: an RCT comparing intra-uterine insemination with expectant management |
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E.1.1.1 | Medical condition in easily understood language |
Fertility in women with endometriosis after their endometriosis surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042391 |
E.1.2 | Term | Subfertility |
E.1.2 | System Organ Class | 100000004872 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014789 |
E.1.2 | Term | Endometriosis, site unspecified |
E.1.2 | System Organ Class | 100000004872 |
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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 |
Compare pregnancy rates using two different strategies among women with a recent surgery for endometriosis: comparison of 4 cycles of intra-uterine insemination (IUI) within 7 menstrual cycles (study group), versus spontaneous evolution during 7 menstrual cycles (control group). Hypothesis: in women receiving IUI the clinical pregnancy rate is significantly higher compared to expectant management.
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E.2.2 | Secondary objectives of the trial |
Evaluate the effect of both strategies on time to pregnancy, treatment cost (study group), need for follicle aspiration (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. age between 18 and 37 (incl)
2. histologically proven endometriosis with complete resection of all endometriosis lesions during laparoscopy at LUFc
3. EFI score of 7 or more
4. Surgery performed not more than 6 months prior to randomization
5. Regular menstrual cycles (min 24days – max 38days) with proven ovulation
6. At least one functional tube at surgery
7. Sperm sample of partner:
normal or mild male factor
fresh sample (not frozen/thawed)
TMC (total motile sperm count after capacitation) minimally 5 million
8. normal uterine cavity (including arcuate uterus) at hysteroscopy and/or hysterosalpingography and/or gel instillation sonography
9. Postoperative hormone testing: basal FSH below 20 IU/l; AMH measurement needs to be available
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E.4 | Principal exclusion criteria |
- frozen (donor or partner) sperm
- clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical pregnancy rate is determined in a 3-step process:
HCG serum measurement at day of ovulation +15; when positive, a second measurement 1 week later
Transvaginal ultrasound between 3 and 8 weeks after ovulation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
HCG serum measurement at day of ovulation +15; when positive, a second measurement 1 week later
Transvaginal ultrasound between 3 and 8 weeks after ovulation |
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E.5.2 | Secondary end point(s) |
time to pregnancy, treatment cost (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate)
need for follicle aspiration (study group), |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
in each IUI treatment cycle: need for follicle aspiration (study group)
at the end of the study: time to pregnancy, treatment cost (study group), multiple pregnancy rate, miscarriage, ectopic pregnancies and delivery rate (live birth rate)
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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 | Yes |
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 |
expectant management compared with Menopur+pregnyl+IUI |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | No |
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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In case of a pregnancy: the trial ens with the end of the pregnancy (miscarriage or delivery)
In case of no pregnancy: the trial ends after 7 menstrual cycles (with a maximum of 4 IUI treatment cycles for the study group) |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |