Recall by Genotype: Neuropeptide Stimulation

Phase 1TerminatedNCT05901467

Stephanie B. Seminara, MD16 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Reproductive Disorder

Interventions

kisspeptin 112-121DRUG

One IV bolus of kisspeptin 112-121

GnRHDRUG

One IV bolus of gonadotropin-releasing hormone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Endogenous LH Pulse Amplitude

Average amplitude of LH pulses at baseline

Time frame: Hours 0-8

Kisspeptin-induced LH Pulse Amplitude

Amplitude of LH pulse in response to kisspeptin

Time frame: Hours 8-11

Data from ClinicalTrials.gov

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