E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects at increased risk of ovarian hyperstimulation syndrome (OHSS). |
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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 |
To investigate whether ovarian hyperstimulation syndrome (OHSS) can be avoided with the delayed start of r-hFSH in ovarian stimulation for IVF treatment in subjects at increased risk of OHSS. |
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E.2.2 | Secondary objectives of the trial |
To study the ability to achieve a reasonable number of ongoing pregnancies with the planned study medication in this trial. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Indication for in vitro fertilisation treatment (IVF) 2. Increased risk of moderate or severe ovarian hyperstimulation syndrome (OHSS) because of polycystic ovary (PCO) or multifollicular ovary (MFO) (ten or more antral follicles in one ovary seen in transvaginal ultrasound (TVU) or because of symptoms or signs of an increased risk of moderate or severe OHSS in previous ovarian stimulations 3. Women aged 18-38 4. Subject is willing and able to participate in the trial and has signed an informed consent form before undergoing any study related activities
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E.4 | Principal exclusion criteria |
1. Pregnancy; 2. History of current disease or concomitant medication known to harm IVF treatment or subsequent pregnancy; 3. More than three previous IVF cycles without conception; 4. BMI >30 kg/m2; 5. Subject’s partner has a severe sperm damage (sperm count < 5 million/ml). (Donated sperm can be used instead) 6. Contraindications of follitropin alfa as defined in the Summary of Product Characteristics (SPC); 7. Allergy to Gonal-f®, clomiphene citrate, Cetrotide® or Ovitrelle® or to any component of these medicines; 8. Current or past (within the last 2 years) abuse of alcohol or narcotics; 9. Ovarian cyst over 30mm at screening visit; 10. Ovarian stimulation for IVF treatment within 30 days before the screening visit; 11. Diabetes, epilepsy, cardiovascular disease, HIV infection; 12. Agents known to affect ovulation (e.g. neuroleptics), drugs known or suspected to be teratogenic which are not routinely used for any of the ART procedures; 13. Blood pressure over 140/90 mmHg; 14. Serum gonadotropin levels (FSH < 3.5 IU/l or > 12IU/l; LH < 2.4 IU/l); 15. Hyperprolactinemia (serum prolactin level > 496 mIU/l) 16. Any other condition, circumstance or previous medication that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects without moderate or severe OHSS (defined by classification adapted from RCOG Green-Top Guideline no 5, 2006) (1).
- Clinical pregnancy rate - Defined by positive pregnancy test (human chorionic gonadotropin (hCG), determined from urinary or serum sample) 14 days after embryo transfer and by presence of a gestational sac assessed by transvaginal ultrasound examination 5 weeks (± 1 week) after embryo transfer. - Number of cycle cancellations (defined as withholding of hCG injection) - Number of subjects with transferable embryos. - Number of subjects having frozen embryos - Severity of OHSS (none, mild, moderate, severe) - Adverse events - Pregnancy outcome up to 12 pregnancy weeks (Oocyte retrieval day = end of the second pregnancy week)
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | |