Clinical trial · Observational
Blood Spot Self-administered Test and Assay
NCT03840824CI-TRIAL-00043341completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysfunction; Endocrine | — | UNRESOLVED | — |
| Effects of Chemotherapy | — | UNRESOLVED | — |
| Premature Ovarian Failure | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cancer Survivor
- description
- Pre-menopausal women who are cancer survivors ages 18-45 years with normal menstrual cycles.
- label
- Similar aged healthy controls
- description
- Pre-menopausal, healthy women ages 18-45 years with normal menstrual cycles
- label
- Late Reproductive Age
- description
- Pre-menopausal, healthy women of late reproductive age
Primary outcomes (1)
- measure
- AMH pg/mL in dried bloodspot vs serum samples
- timeFrame
- Day 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMcDade 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