A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI - OXOART 2 (OXO-001 in Assisted Reproductive Technology, phase 2 trial)

Oxolife S.L.0 sites351 target enrollmentJuly 27, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Oxolife S.L.

•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.
•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.

•1\. History of two or more failed (no clinical pregnancy) in\-vitro fertilisation (IVF) / intra\-cytoplasmic sperm injection (ICSI) cycles after embryo transfer of donor oocyte during the last attempts prior to the trial.
•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.