Blood Spot Self-administered Test and Assay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Performance Evaluation of AMH Assay

NCT03131388

Anti-Mullerian Hormone

COMPLETED

Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders

NCT03826888

Anti-Mullerian Hormone Isoforms

COMPLETED

A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

NCT00544882

Healthy

COMPLETED PHASE3

Oral Contraceptive Efficacy and Body Weight

NCT00662454

Contraception Body Weight

COMPLETED PHASE4

Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP

NCT03197961

HIV/AIDS Contraception

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysfunction; Endocrine Effects of Chemotherapy Premature Ovarian Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cancer Survivor

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

No interventions assigned to this group

Similar aged healthy controls

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

No interventions assigned to this group

Late Reproductive Age

Pre-menopausal, healthy women of late reproductive age

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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