E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypothesis. By combining pituitary downregulation with aromatase inhibitor, and hCG injection during a late luteal phase a powerful stimulation of thecal androgen production is achieved. Thereby, it is expected that the later FSH stimulation will result in growth and pre-ovulatory development of significantly more follicles in women with a previously proven poor response to standard hormone treatment in IVF cycles. The present study is designed to meet these requirements.
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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 |
OBJECTIVES: To evaluate effects of late luteal phase androgen priming to enhance follicle growth and improve sensitivity to FSH stimulation in normogonadotropic women with a proven poor response to standard hormone stimulation for IVF. Each patient thus serves as her own control
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E.2.2 | Secondary objectives of the trial |
SECONDARY ENDPOINTS: To evaluate the effects of this hormonal regime on ovarian androgen production and follicular development by measuring the following parameters 1) on cycle day 24 (start of treatment), 2) on the day of administration of aromatase inhibitor and hCG, and 3) five days later, i.e. on FSH stimulation day 1:
I) Concentrations of androstenedione, testosterone, anti-müllerian hormone (AMH), Inhibin B, østradiol, FSH, LH in the circulation.
II) Number of antral follicles with diameter ≥ 2mm as visualized by vaginal ultrasound on the three occasions 1), 2) and 3) mentioned above
In addition: III) The follicular development; number of follicles > 10mm, > 14 mm and > 17 mm on S8, HCG- and OPU-day.
IV) Se-oestradiol per follicle > 10 mm on S8, hCG-day and OPU-day.
V) Total consumption of FSH and LH
VI) Rate of biochemical and clinical pregnancy
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria; Normogonadotropic, healthy women < 40 years old, who in a previous IVF or ICSI attempt has shown the characteristics of a low responder as defined above. |
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E.4 | Principal exclusion criteria |
Exclusion criteria; Any clinically significant systemic disease (e.g., insulin dependent diabetes) or endocrine/metabolic disease, any concomitant medications that would interfere with evaluation of study medications (non-study hormonal therapy - except for thyroid medication, NSAIDs - including aspirin, and psychotropic agents (phenothiazine’s, major tranquillisers) at the time of study entry and during the study. Abuse of alcohol or drugs, history of chemotherapy or radiotherapy, any clinically relevant abnormal laboratory value, use of any non registered investigational drugs during 3 months before screening or previous participation in the study, pregnancy, lactation or contraindication to pregnancy – must be confirmed by negative pregnancy test on CD 24. i.e. at the time of entry into the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
PRIMARY ENDPOINTS: Number of oocytes retrieved and fertilised, and number of transferable embryos in comparison with the patient’s immediate previous IVF cycle, in which a low response was recorded.
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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 | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
patients are there own control in this trial |
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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 | No |
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 | Information not present in EudraCT |
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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Patient inclusion will be for a period of 12 months or as soon as 20 patients have been included |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |