E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women with a clinical indication to undergo Assisted Reproductive Technologies for infertility with a predicted normal response to Ovarian Stimulation and planned for a single blastocyst transfer |
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E.1.1.1 | Medical condition in easily understood language |
Women with a clinical indication to undergo Assisted Reproductive Technologies for infertility with a predicted normal response to Ovarian Stimulation and planned for a single blastocyst transfer |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered for ovarian stimulation. |
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E.2.2 | Secondary objectives of the trial |
- To compare the variation of serum progesterone (P4) throughout ovarian stimulation (OS) according to the type of gonadotropins administered; - To evaluate the influence of P4 variation throughout OS on the endometrial gene expression; - To assess how an individualized stepdown protocol may affect serum P4 concentrations, oocyte retrieval (OR) rates and the endometrial gene profile.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent form (ICF) dated and signed. 2. Age: ≥18 and <40 years old. 3. Antral follicular count (AFC): ≥5 and <20. 4. Anti-Müllerian Hormone (AMH): ≥1.1 ng/mL and <2.5 ng/mL, performed in the 12 months prior to inclusion. 5. Body Mass Index (BMI): ≥18.5 Kg/m2 and <30 Kg/m2. 6. Weight: ≥50 kg and <80 kg. 7. First or second Assisted Reproductive Technologies (ART) cycle or fertility preservation cycle. 8. Regular menstrual cycles (between 22 and 35 days). 9. Two ovaries present. 10. Pregnancy-wish. 11. Planned for single blastocyst transfer |
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E.4 | Principal exclusion criteria |
1. Simultaneous participation in another clinical study. 2. Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or Ovarian hyperstimulation syndrome (OHSS), regardless of gonadotropin dose. 3. Known reasons for impaired implantation (specifically hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis). 4. Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous miscarriages). 5. Recurrent implantation failure (>3 failed cycles with good quality embryos). 6. Polycystic ovary syndrome (PCOS). 7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus. 8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. 9. Ovarian cysts or enlarged ovaries. 10. Fibroid tumours of the uterus incompatible with pregnancy. 11. Malformations of the reproductive organs incompatible with pregnancy. 12. Primary gonadal failure. 13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2 determined by the Modified Diet and Renal Disease (MDRD) equation at screening. 14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin). 15. Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia. 16. Moderate or severe hepatic impairment. 17. Untreated and uncontrolled thyroid dysfunction. 18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids, anti-epileptics or chemotherapy. 19. Administration of exogenous Estradiol (E2), P4 or gonadotropins in the preceding menstrual cycle. 20. Active female smoking. 21. Acceptors of donated oocytes/embryos. 22. Ongoing pregnancy. 23. Women who have previously enrolled in the trial. 24. Those unable to comprehend the investigational nature of the proposed study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered for ovarian stimulation (OS).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 |
To assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered for ovarian stimulation (OS). |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.2.4 | Number of treatment arms in the trial | 3 |
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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Visit 10 - 5 days after Oocyte Retrieval (OR) |
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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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |