Infertility treatment and fertility enhancer in women undergoing assisted reproductive techniques or natural reproduction
Conditions
Interventions
Sponsors
Oxolife S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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) ;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: At the end of the main part of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: At the end of the main part of the trial. | — |
Countries
Czech Republic, Poland, Spain
Contacts
Public ContactCEO
Oxolife S.L.
Outcome results
None listed