Blood Spot Self-administered Test and Assay

University of Pennsylvania

Status: Completed

Conditions: Effects of Chemotherapy; Dysfunction; Endocrine; Premature Ovarian Failure

Study type: Observational

Funder types: Other

Identifiers

NCT03840824

812735

Details and patient eligibility

About

The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.

Full description

Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.

Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult females
• Age between 18-45 years
• Premenopausal (defined as menses in the past 12 months)
• Postmenarchal
• Presence of an intact uterus and two ovaries
• Ability and willingness to comply with study protocol

Exclusion criteria

• Pregnancy within the previous 3 months
• Lactation within the previous 3 months

Trial design

80 participants in 3 patient groups

Cancer Survivor

Description:

Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles.

Similar aged healthy controls

Description:

Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles

Late Reproductive Age

Description:

Pre-menopausal, healthy women of late reproductive age