Recall by Genotype: Neuropeptide Stimulation

January 19, 2024 updated by: Stephanie B. Seminara, MD
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kisspeptin, GnRH
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
Drug: kisspeptin 112-121
One IV bolus of kisspeptin 112-121
Other Names:
  • metastin 45-54
Drug: GnRH
One IV bolus of gonadotropin-releasing hormone
Other Names:
  • gonadotropin-releasing hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endogenous LH pulse amplitude
Time Frame: Hours 0-8
Average amplitude of LH pulses at baseline
Hours 0-8
Kisspeptin-induced LH pulse amplitude
Time Frame: Hours 8-11
Amplitude of LH pulse in response to kisspeptin
Hours 8-11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie B. Seminara, MD

Investigators

  • Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 326733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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