Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Dono… (NCT05076032) | Clinical Trial Compass
CompletedPhase 2
Phase II Clinical Trial to Evaluate the Ongoing Pregnancy Rate With OXO-001 in IVF/ICSI With Donor Oocytes.
Czechia408 participantsStarted 2021-09-01
Plain-language summary
The main objective of this clinical research trial is to test the efficacy of OXO-001 in a daily oral administration increasing the pregnancy rate in IVF/ICSI by preparing the uterus to receive the embryo.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* Voluntary informed consent.
* Infertile female subjects indicated for egg donor programme in the context of ART.
* Subjects aged ≥ 18 to ≤ 45 years at screening.
* Body mass index (BMI) ≥ 18.0 and \< 30.0 kg/m2.
* Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening.
* Planned transfer of a fresh single blastocyst from a donated egg.
* Good quality sperm.
* Planned endometrial preparation and luteal support.
Exclusion Criteria:
* History of two or more failed in-vitro fertilisation (IVF) / intra-cytoplasmic sperm injection (ICSI) cycles after embryo transfer of donor oocyte during the last attempts prior to the trial.
* Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives.
* Abnormal haemorrhage of the reproductive tract of undetermined origin.
* Endometrial biopsy or endometrial local injury within one month prior to screening.
* Diagnosis of severe endometriosis and/or adenomyosis.
* Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results.
* Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
* Systemic disease which might interfere with the purpose of the trial.
* Any malignant neoplasm.
* Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of…