Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT05076032
Eligibility Criteria:
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 clotting.
* History of uncontrolled hypertension.
* Known hypersensitivity to any component of the IP used in this trial.
* Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
* History (within 12 months) of or known current problems with alcohol or substance abuse.
* Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
* 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.
* 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.
* Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05076032
Study Brief:
Protocol Section:
NCT05076032