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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT04686357
Eligibility Criteria:
* Inclusion criteria
* Patients whose written IC approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
* Patients undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing all) with their own oocytes that will receive single embryo transfer of frozen blastocyst stage embryos (day 5/6) on an HRT cycle.
* At least 2 morphologically good quality embryos already vitrified in blastocyst stage (day 5/6).
* Maternal Age: ≤37 years to rule out embryo factor in aging patients.
* BMI: 18.5 - 30.0 kg / m2 (both inclusive).
* Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH \< 8 mU/ml) before the controlled ovarian stimulation (COS) initiation.
* Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG administration in the COS cycle.
* Negative serological tests for HIV, HBV, HCV, RPR.
* Exclusion criteria
* Patients with repeated miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages).
* Male partner with severe male factor (spermatozoa \< 2 million/ml). Semen donor is allowed.
* Patients who are intrauterine device (IUD) carriers in the last 3 months before sample collection.
* Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx must be previously operated at least 3 months before the endometrial samples are obtained.(Note: Patients are allowed to participate if the pathology is corrected before performing any study procedure).
* Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A)
* Women who have received antibiotics in the last month previous to sample collection, except for the prophylaxis for the oocyte retrieval. In the control group, antibiotics cannot be provided during the ET cycle
* Illness or unstable medical condition that may put at risk the patient's safety and her compliance in the study
Healthy Volunteers:
True
Sex:
FEMALE
Maximum Age:
37 Years
Study:
NCT04686357
Study Brief:
Protocol Section:
NCT04686357