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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT06581068
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed by the patients before treatment.
* Medical indication to perform assisted reproductive technology.
* Body mass index between 20 and 29 kg/m2 (female participants only).
* For women with indication of utilizing autologous eggs:
* Anti-Müllerian Hormone (AMH) value of at least 1.5 ng/mL.
* 18 - 39 years of age.
* For women utilizing donor eggs (egg donor age 18-28 years):
* 18 - 45 years of age.
Exclusion Criteria:
* Patients diagnosed with recurrent pregnancy loss.
* Inaccessible ovaries for puncture.
* History of total or partial fertilization failure in a previous fertility treatment.
* History of repeated implantation failure defined as three previous unsuccessful embryo transfers.
* Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at the discretion of the medical team and based on its impact on success and/or risk to the patient or the pregnancy may compromise treatment prognosis).
* Untreated hydrosalpinx
* Severe endometriosis III, IV, presence of endometriomas and/or history of endometrioma resection.
* Polycystic ovarian syndrome.
* Patients with any of the following severe male factor infertility:
* Sperm concentrations less than 5 million per mL
* Progressive motility less than 5%
* Others (e.g, globozoospermia and seminal infections) at the discretion of the medical team and based on its impact on success.
* Surgically retrieved sperm (TESE, MESA, PESA)
* Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronic degenerative and autoimmune diseases, uncontrolled hormonal disorders).
* Any other case of abnormalities that could compromise success rates according to the criteria of clinical personnel in charge.
* Inability to adhere to the medical protocols and/or schedules for personal reasons.
* Intercurrent medical disorder
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06581068
Study Brief:
Protocol Section:
NCT06581068