E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women diagnosed with unexplained subfertility or mild male factor subfertility with an indication for intra uterine insemination |
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E.1.1.1 | Medical condition in easily understood language |
Women diagnosed with unexplained subfertility or mild male factor subfertility with an indication for intra uterine insemination |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021926 |
E.1.2 | Term | Infertility |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
To compare the cumulative ongoing pregnancy rates of 4 IUI cycles with either FSH or CC
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E.2.2 | Secondary objectives of the trial |
In addition we aim to answer the following questions:
What is the difference between 4 cycles of super ovulation with IUI-FSH or IUI-CC in terms of ongoing pregnancy;
- The effectiveness of IUI-FSH compared to IUI-CC in a time horizon of 6 months.
- What is the cost of 4 cycles of IUI-FSH compared to 4 cycles of IUI-CC.
- What is the willingness to pay by patients, measured by means of a discrete choice
experiment (DCE)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- At least 12 months of unprotected intercourse without conception.
- At least one sided tubal patency, which is established according to local protocol.
- The male partner or semen-donor has normal semen quality or mild impairment of semen
quality. Mild male subfertility is defined as abnormal semen parameters according to the
WHO but an average total motile sperm account before processing of at least 10 million.
- The 12-month prognosis for the couple to conceive naturally has to be below 30%
according to the model of Hunault. |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Double sided tubal pathology.
- Women with irregular cycles, PCOS or other endocrine disorders.
- Impaired semen quality: pre-wash TMC < 10 million.
- Women younger than 18 of older than 43 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative ongoing pregnancy rate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
ultrasound at gestational age of 12 weeks |
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E.5.2 | Secondary end point(s) |
1. Number of cycles with monofollicular growth
2. Number of cycles with multiple follicle growth
3. Number of cancelled cycles due to the occurrence of >3 follicles >15 mm
4. Difference in severity of known adverse effects
5. Time to ongoing pregnancy rate
6. Clinical pregnancy
7. Miscarriage rate
8. Live birth rate
9. Multiple pregnancies
10. Patients preference by DCE
11. Direct and indirect costs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 12 weeks pregnancy
- birth |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
FSH compared to clomifene citrate |
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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
| 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 | 18 |
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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The end of the study is defined as the last patient’s last visit, in case of pregnancy at 12 weeks gestation. |
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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 | |