Recall by Genotype: Neuropeptide Stimulation

Reproductive Disorder Clinical Trial

Official title:

Recall by Genotype: Neuropeptide Stimulation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05901467
• Other study ID #: 326733
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: October 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• No prescription medications that could interfere with hypothalamic reproductive function
• No illicit drug use
• No excessive alcohol consumption (more than 10 drinks/week)
• No history of an allergic medication reaction requiring emergency medical care
• Normal blood pressure reading (systolic blood pressure < 140 mm Hg, diastolic < 90 mm Hg)
• White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
• Normal hemoglobin
• Blood urea nitrogen (BUN), creatinine not elevated
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal
• Enrolled in the Partners HealthCare Biobank and genotypically characterized
• For women
• No oral contraceptives for at least 1 month
• No contraceptive implants for at least 3 months
• Not breastfeeding and not pregnant
• Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)

Related Conditions & MeSH terms

• Reproductive Disorder

Intervention

Drug:
• kisspeptin 112-121
One IV bolus of kisspeptin 112-121
• GnRH
One IV bolus of gonadotropin-releasing hormone

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous LH pulse amplitude	Average amplitude of LH pulses at baseline	Hours 0-8
Primary	Kisspeptin-induced LH pulse amplitude	Amplitude of LH pulse in response to kisspeptin	Hours 8-11