E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 demonstrate that highly purified Menotrophin produces significant lower progesterone (P4) serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing IVF using a GnRH antagonist protocol for pituitary down-regulation. |
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E.2.2 | Secondary objectives of the trial |
to investigate
• if the progesterone serum levels during the follicular phase might be a useful predictor for the success rate of the ongoing-pregnancy rates in the Menotrophin (HP-hMG) group and the Follitropin alpha group.
• if highly purified Menotrophin is non-inferior or whether there are differences existing to Follitropin alpha in the treatment of subfertile females in an IVF programme with respect to efficacy and safety.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent
2. Subfertile premenopausal female patients eligible for IVF treatment
3. Aged >=34 and <= 42 years
4. Body mass index of >18 and <28 kg/m2
5. Normal pelvic ultrasound at Screening I (Visit 1)
6. No more than two previous gonadotrophin stimulated cycles of IVF or ICSI in the history
of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not
count; Clomifen cycles are no exclusion criterion)
7. At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months prior to Screening I
8. No fertility stimulating drugs at all within the last 3 months prior to treatment start (Visit 3)
9. Sperm of partner classified as normal according to WHO 2010 criteria within the year prior to Visit 3
10. Negative urine beta human chorionic gonadotrophin (hCG) pregnancy test at Screening II (Visit 2)
11. Clinically normal baseline haematology, clinical chemistry, and urinalysis values at Screening I
12. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening I
13. Endocrine test results (E2, LH, FSH, P4, AMH (>1ng/ml), prolactin, TSH) in early follicular phase within the clinically normal limits at Screening
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E.4 | Principal exclusion criteria |
1. Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus)
2. A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
3. A history of coagulation disorders
4. Persistent ovarian cysts (>3 months)
5. Contraindications for the use of gonadotrophins or GnRH antagonists
6. A history of hypersensitivity to any of the constituents of the study medication or related compounds
7. A history of alcohol abuse (more than 30 units per week on a regular basis)
8. History of chemo- or radiotherapy
9. Currently breast-feeding, pregnant or with a contraindication to pregnancy
10. Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
11. History of severe OHSS (grade 4 or 5) in former gonadotrophin stimulated ART-cycle
12. Investigational drug within the last 30 days prior to Visit 3 or former enrolment into this study
13. Any other condition or history that the Investigator considers might increase the risk to the individual
14. Incapability to understand the aim, importance and consequences of the study and to give legal informed consent
15. Institutionalization due to regulatory or judicial order
16. Possible dependence on the Sponsor or Investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is the serum progesterone (P4) level in the morning of the day of hCG administration. |
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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 | Yes |
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 | 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) | Yes |
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
| 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 | 7 |
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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Last visit (Visit 12) of last subject. |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |