Blood Spot Self-administered Test and Assay

NCT03840824 | Completed

• 1 other identifier: 812735
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysfunction; Endocrine; Effects of Chemotherapy; Premature Ovarian Failure

Keywords

healthy; premenopausal; postmenarchal; chemotherapy; alkylating agent; alkylator; high dose cancer therapy; low dose cancer therapy

Outcome Measures

Primary Outcomes (1)

• AMH pg/mL in dried bloodspot vs serum samples

  Serum AMH ELISA assay results will be compared to capillary blood sample AMH collected on filter paper and dried. Recovery of spiked ligands, sensitivity and specificity of the assays will be also assessed.

  Day 1

Secondary Outcomes (5)

• Adequacy of subject's self-collected bloodspot sample vs. sample collected in clinic

  Day 1

• Measures of user acceptability through subject report/feedback

  Day 1

• AMH pg/mL in cancer survivors vs. healthy control cohorts

  Day 1

• FSH (mIU/mL) in dried bloodspot vs serum samples

  Day 1

• Inhibin B (pg/ml) in dried bloodspot vs serum samples

  Day 1

Study Arms (3)

Cancer Survivor

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

Similar aged healthy controls

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

Late Reproductive Age

Pre-menopausal, healthy women of late reproductive age

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population is 80 pre-menopausal women ages 18-45 years with normal menstrual cycles: Aim 1: Total 80 subjects: * 30 cancer survivors * 30 similar aged healthy controls * 20 late reproductive aged women Aim 2: Subset of 60 subjects: * 30 cancer survivors * 30 similar aged healthy controls

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Reproductive Research Unit

Philadelphia, Pennsylvania, 19143, United States

Location

Related Publications (1)

• McDade TW, Woodruff TK, Huang YY, Funk WE, Prewitt M, Kondapalli L, Gracia CR. Quantification of anti-Mullerian hormone (AMH) in dried blood spots: validation of a minimally invasive method for assessing ovarian reserve. Hum Reprod. 2012 Aug;27(8):2503-8. doi: 10.1093/humrep/des194. Epub 2012 Jun 6.

  PMID: 22674205 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Clarisa Gracia, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: February 15, 2019
• Study Start: October 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

US (1)