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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT05279560
Eligibility Criteria:
Inclusion Criteria:
* Serum AMH \< 0.5 ng/ml (at screening visit and in the absence of OC or sex-steroid intake)
* Antral follicular count (AFC) in both ovaries ≤ 5 (at screening visit and in the absence of OC or sex-steroid intake)
* Spontaneous cycle, menstrual cycle length 21-35 days
* Body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2
* Both ovaries must be visible by transvaginal ultrasound examination
* Both ovaries must be judged accessible by transvaginal puncture
* Indication for IVF or ICSI treatment
* Willingness to participate and provide written consent prior to initiation of any study-related procedures
* The subject and male partner must agree to participate in the infant follow-up if she becomes pregnant
* The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
Exclusion Criteria:
* ≥ four cumulus-oocyte-complexes (COCs) retrieved in a previous IVF cycles with a conventional stimulation protocol (within 6 months before enrollment)
* Serum value of FSH ≥25 IU/l (within 12 months measured in the absence of OC or hormone replacement intake)
* Thrombocytopenia defined as \< 100.000 platelets/µl at screening
* Oral contraceptive or sex steroid intake within 1 month prior to enrollment
* Presence of structural or numerical chromosomal abnormality in cytogenetic analysis
* Relevant autoimmune disease
* History of malignancy and systemic chemotherapy or pelvic radiation
* Severe endometriosis (stage III-IV)
* Ovaries located outside the inner pelvis
* Presence of unilateral or bilateral hydrosalpinx
* Relevant endocrine disorders such as hypothalamic-pituitary disorder or thyroid dysfunction (except substituted Hashimoto's thyroiditis or latent hypothyroidism)
* Relevant thrombophilic disorder
* Contraindication for pregnancy
* Contraindication for transvaginal ovarian puncture (such as previous major lower abdominal surgery and known severe pelvic adhesion)
* Uterine malformations or pathologies (such as sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions)
* Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT05279560
Study Brief:
Protocol Section:
NCT05279560