E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ovarian stimulation in oocyte donation |
Ovariestimulation ved ægdonation |
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E.1.1.1 | Medical condition in easily understood language |
Ovarianstimulation in oocyte donation |
Ægstimulering ved ægdonation |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071130 |
E.1.2 | Term | Controlled ovarian stimulation |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072100 |
E.1.2 | Term | Egg donor |
E.1.2 | System Organ Class | 100000004869 |
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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 |
The goal of the trial is to determine wheather co-treatment with aromatase inhibitor in ovarian stimulation in egg donors normalize the length of the unsupported luteal phase, reduce the endometrium thickness, positively modulate endocrine markers of luteal phase quality and endometrial markers of receptivity. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Meet the clinical criteria for acceptance as oocyte donors Regular ovulatory cycle of 26-30 days. Age: ≤ 35 years (the age limit for donating eggs in Denmark) Written consent
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E.4 | Principal exclusion criteria |
Contraindications for ovarian stimulation or OPU according to local guidelines PCOS Allergy towards study drug
Exclusion of patients after earlier inclusion in the study in case of - Patient withdrawal of consent - Lack of compliance with medication - Medical complications arising from IVF treatment that requires the cycle to be terminated - Serious adverse event (SAE) or serious adverse reaction (SAR) including severe allergy to study drug. - Specific adverse reactions to study drug: severe degree of hot flushed, severe degree of nausea/vomiting, severe diarrhea, severe degree of muscle and joint pain.
In case of exclusion of a patient after earlier inclusion in the study, a new patient will be included.
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in lengths (days until bleeding) of the luteal phase between interventions group and controls.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Patients will start bleeding (menstruation) within two weeks after oocyte pickup. Patients will registry that date. |
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E.5.2 | Secondary end point(s) |
Difference in established endometrial tissue and secretion markers of endometrial receptivity between intervention group and controls. Differences in the area under the curve for plasma E2, P, LH and FSH levels from day of OPU until day 14 post OPU between intervention group and controls. Difference in endometrium thickness 7 days post OPU between intervention group and controls.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Difference in established endometrial tissue and secretion markers of endometrial receptivity between intervention group and controls: Endometrial secretion sample 7 days after oocyte pickup. Differences in the area under the curve for plasma E2, P, LH and FSH levels from day of OPU until day 14 post OPU between intervention group and controls: Blood Collection on day of oocyte pick up, 7 days after and 14 days after oocyte pick up. Difference in endometrium thickness 7 days post OPU between intervention group and controls: uterine ultrasound 7 days after oocyte pickup.
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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) | 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 | 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 |
Conventional treatment, no placebo used |
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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 | 2 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |