E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infertility treatment and fertility enhancer in women undergoing assisted reproductive techniques or natural reproduction |
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E.1.1.1 | Medical condition in easily understood language |
Female Infertility and Improvemet of fertility |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 |
The primary objective of this trial is to assess the efficacy of oral OXO-001 (200 mg and 300 mg) versus placebo taken once-daily to increase the ongoing pregnancy rate (defined as the rate of intrauterine pregnancy with foetal heartbeat) at 10 weeks post embryo transfer (ET) |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this trial is to assess the efficacy of OXO-001 (200 mg and 300 mg) versus placebo in terms of biochemical pregnancy rate and pregnancy loss rate until 10 weeks post ET and to assess the safety and tolerability of OXO-001 (200 mg and 300 mg) from the first administration until 10 weeks post ET. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Voluntary written informed consent before initiation of any trial-related procedures, including the agreement to participate in the pregnancy and infant follow-up if becoming pregnant. 2. Infertile female subjects indicated for egg donor programme in the context of ART. Infertility is defined as the failure to achieve a clinical pregnancy after: a. at least 12 months of regular unprotected sexual intercourse, if < 35 years of age, b. at least 6 months of regular unprotected sexual intercourse, if ≥ 35 years of age. 3. Subjects aged ≥ 18 to ≤ 45 years at screening. 4. Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2. 5. Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening (no presence of gynaecological abnormality suspected to affect the ART procedure and outcome). The TVUS should have been performed in the mid of the second part of a menstrual cycle. . 6. Planned transfer of a fresh single blastocyst from a donated egg. 7. Good quality sperm (fresh or frozen) available from partner or donor. Sperm assessment must not be older than 6 months prior to screening (fresh and frozen sperm). NOTE: The partner’s consent on the review of his medical source data to assess sperm quality and for the potential use of donor sperms, as applicable, is required. 8. Planned endometrial preparation (not natural) and luteal support. |
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E.4 | Principal exclusion criteria |
1. History of failed IVF/ICSI cycles with donor oocyte (each embryo transfer counts as a cycle). As an exception subjects with one previous failed cycle with donor oocyte are eligible only if this resulted in a confirmed biochemical pregnancy (positive B-human chorionic gonadotropin (B-hCG) test) during that cycle. 2. Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives (e.g. significant uterine anomaly, communicating hydrosalpinx or submucosal/intramural fibroid(s) that deform the uterine cavity, congenital malformations) documented during transvaginal sonography. 3. Abnormal haemorrhage of the reproductive tract of undetermined origin. 4. Endometrial biopsy or endometrial local injury within one month prior to screening. 5. Diagnosis of severe endometriosis (stage III or IV) and/or adenomyosis. 6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results. 7. Relevant clinically significant abnormality in the results of safety laboratory tests at screening. 8. Systemic disease (e.g. diabetes, epilepsy, severe migraine, hepatic, renal or cardiovascular disease, severe oral corticosteroid-dependent asthma, autoimmune disease, thrombophilia disease) which might interfere with the purpose of the trial. 9. Any malignant neoplasm. 10. Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting. 11. History of uncontrolled hypertension. 12. Known hypersensitivity to any component of the IP used in this trial. 13. Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg. 14. History (within 12 months) of or known current problems with alcohol or substance abuse. 15. Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol. 16. Previous treatment with the IP of this trial at any time or participation in another clinical trial within the past 3 months prior to screening. 17. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator. 18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be assessed using the ongoing pregnancy rate, defined as the rate of subjects with uterine pregnancy and a foetal heartbeat, confirmed by ultrasound (US) at 10 weeks post embryo transfer. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the main part of the trial.
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E.5.2 | Secondary end point(s) |
1. Percentage of women with positive blood pregnancy test 10 to 15 days post ET. 2. Percentage of women with vital pregnancy (defined as intra-uterine pregnancy with foetal heartbeat) at 6 weeks post ET. 3. Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10 - 15 days post ET). 4. Incidence and severity of AEs/ SAEs, reported during the period from the first intake of the IP until 10 weeks post ET. 5. Changes from baseline in haematology and biochemistry values 6 weeks post ET. 6. Changes from baseline in vital signs (heart rate, blood pressure). 7. Changes in endometrial thickness. 8. Proportion of subjects achieving the endometrial criteria to undergo ET. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of the main part of the trial.
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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 | Yes |
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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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
| 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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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LVLS (main part of 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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |