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 |
Infertility is a term doctors use if a woman hasn't been able to get pregnant after at least one year of trying. |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016399 |
E.1.2 | Term | Female infertility (primary) |
E.1.2 | System Organ Class | 100000004872 |
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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 primary objective of this study is to investigate in a paired design if eight weeks of hCG pre-treatment improves responsiveness to ovarian stimulation during IVF/ICSI in women with low ovarian reserve. |
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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 |
Age 18-40 (both inclusive); regular menstrual cycle between 23 and 35 days; AMH < 6.29 pmol/L, willingness to undergo two consecutive identical controlled ovarian stimulations with a freeze-all strategy employed after the first stimulation. |
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E.4 | Principal exclusion criteria |
Exclusion criteria are uterine malformations, submucosal myomas, intrauterine polyps, hydrosalpinx, endometriosis stage III-IV, severe comorbidity (i.e. IDDM, NIDDM, gastrointestinal, cardiovascular, pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulation of thyroid disease), need for testicular sperm aspiration, preimplantation genetic testing, not Danish or English speaking, previous inclusion, or allergy to Ovitrelle or other standard IVF medication. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Follicular output rate (FORT) = the proportion of the antral follicle count that reach the pre-ovulatory stage. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the IVF study cycle. |
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E.5.2 | Secondary end point(s) |
•Antral follicle count (2-10 mm) at baseline (cd 2-3)
•AMH at baseline (cd 2-3)
•Number of pre-ovulatory follicles >16 mm on trigger day
•Number of follicles >14 mm and >12 mm >10 mm and ≤10 mm on hCG trigger day
•Number of oocytes retrieved
•Number of mature (MII) oocytes
•Number of fertilized eggs (2pn)
•Number of cleaved day 2 embryos
•Number of good quality day 2 embryos
•Number of top quality day 2 embryos
•Number of blastocysts (Gardner score 1-6)
•Number of good quality blastocysts day 5/6
•Number of vitrified embryos/blastocysts
•Total number of transferred or vitrified blastocysts
•The number of cancelled cycles and the reasons for cancellation in the two groups
•Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione)
•Granulosa/cumulus cell FSH and LH receptor expression
•Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the control and study cycle and regarding cumulus and granulosa cell investigations no later than one year after inclusion of the last patient. |
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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) | 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 | 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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| 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 | 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 |