NCT05901467

Recall by Genotype: Neuropeptide Stimulation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Stephanie B. Seminara, MD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.

Detailed description

Assignment: All study subjects will undergo the same interventions. Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility). Delivery of Interventions: * Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories. * On the day of the study, the subjects will have an intravenous (IV) line placed and * Undergo up to q10 min blood sampling x 12 hours * Receive a single kisspeptin IV bolus at hour 8 * Receive a single GnRH IV bolus at hour 11

Conditions

• Reproductive Disorder

Interventions

Type	Name	Description
DRUG	kisspeptin 112-121	One IV bolus of kisspeptin 112-121
DRUG	GnRH	One IV bolus of gonadotropin-releasing hormone

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-05-29
• Completion: 2024-05-29
• First posted: 2023-06-13
• Last updated: 2026-03-06
• Results posted: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study