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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT01343368
Eligibility Criteria:
Inclusion Criteria:
* Interventional Arm:
* Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)
* Post-menarchal female \< or = 50 years of age
* Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty
* Those women who have an FSH \> 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
* Observational Arm:
* Eligible for reduced intensity allogeneic HCT
* Post-menarchal female ≤ 50 years of age
* Normal AMH level and/or FSH/LH for age/stage of puberty
* Those women who an FSH \>40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
Exclusion Criteria:
* All Arms:
* History of ovarian cancer
* Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.
* Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT01343368
Study Brief:
Protocol Section:
NCT01343368