E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 10021928 |
E.1.2 | Term | Infertility female |
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 evaluate the effect of barusiban compared to placebo on implantation rate in IVF/ICSI patients |
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E.2.2 | Secondary objectives of the trial |
– To evaluate the effect of barusiban compared to placebo on pregnancy rates
– To explore the pharmacokinetics of subcutaneous administration of barusiban
– To evaluate the safety profile of barusiban
– To evaluate the local tolerability of barusiban |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women aged 18-37 years
- Women who have undergone 2-4 previous fresh IVF/ICSI cycles that all resulted in a negative βhCG test, despite transfer of at least one embryo/blastocyst of good quality
- Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long GnRH agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer
- Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle
- Subjects should have at least one embryo of good quality available for transfer on day 3, or one expanded or hatching/hatched blastocyst available for transfer on day 5 |
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E.4 | Principal exclusion criteria |
- A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI
- Abnormal karyotype
- Uterine pathology or hydrosalpinx
- Diagnosed with acquired or congenital thrombophilia disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
– Ongoing implantation rate (number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos/blastocysts transferred) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
– Ongoing implantation rate:10-11 weeks after transfer |
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E.5.2 | Secondary end point(s) |
– Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11 weeks after transfer)
– Implantation rate (number of intrauterine gestational sacs with fetal heart beat 5-6 weeks after transfer divided by number of embryos/blastocysts transferred)
– Clinical pregnancy (with fetal heart beat) rate (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)
– Positive βhCG rate (positive serum βhCG test 13-15 days after transfer)
– Serum barusiban concentration at the expected tmax
– Frequency and intensity of adverse events
– Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed immediately and 30 min after each administration of barusiban / placebo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
– Ongoing pregnancy rate: 10-11 weeks after transfer
– Implantation rate: 5-6 weeks after transfer
– Clinical pregnancy: 5-6 weeks after transfer
– Positive βhCG rate:13-15 days after transfer
– Serum barusiban concentration: 30 min after last barusiban / placebo dose
– Frequency and intensity of adverse events: from signed informed consent to end-of-trial
– Frequency and intensity of injection site reactions: immediately and 30 min after each administration of barusiban / placebo |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
Poland |
Czech Republic |
Spain |
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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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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |