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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01448460
Eligibility Criteria:
Inclusion Criteria:
* Women between the ages of 18 and 37 and who require IVF for a successful pregnancy will be approached to consent for the study,. They must also have a cycle day 3 FSH \< 10 mIU/ml, estradiol \< 70 pg/ml and a baseline follicle count \> 10. The BMI must be between 20 and 32kg/m2. If they do consent, eggs will only be vitrified if 13 or more mature metaphase II oocytes are collected.
* Women between the ages of 14 and 42 who are seeking treatment for fertility preservation. In addition they must also meet the following criteria.
* Patient is willing and able to delay any relevant therapy for up to 40 days.
* Have functioning ovaries as determined by blood / ultrasound testing.
* Patient is willing to undergo infectious disease testing for HIV, hepatitis B and C, syphilis, gonorrhea and Chlamydia.
* The patient must have clearance from their oncologist or medical specialist, if any, to undergo ovarian stimulation and transvaginal oocyte retrieval.
* The patient must not have a past history of blood clots in the veins or in the lungs.
* The patient must be willing to undergo transvaginal, internal ultrasound examination and pelvic examination.
Exclusion Criteria:
* Patients with a cycle day 3 FSH \> 10 mIU/ml, cycle day 3 estradiol \> 70 pg/ml and a baseline follicle count \< 10 will be excluded.
* Patients with a BMI \<20 and \>32 will be excluded.
* Patients who are not willing or are unable to meet the above mentioned eligibility requirments.
* Patients with expected low ovarian reserve \[evaluated on day 3 by an antral follicle count of \<3 follicles at 2-5 mm diameter and/or an increased concentration of follicle stimulating hormone (FSH) \>15 IU \[15\] on cycle day 3 \].
* Patients with possible poor quality of oocytes, based on medical history including previous exposure to chemotherapeutics or radiation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
42 Years
Study:
NCT01448460
Study Brief:
Protocol Section:
NCT01448460