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Recall by Genotype: Neuropeptide Stimulation

Sponsor
Stephanie B. Seminara, MD (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05901467
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
30.1
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Recall by Genotype: Neuropeptide Stimulation
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endogenous LH pulse amplitude [Hours 0-8]

      Average amplitude of LH pulses at baseline

    2. Kisspeptin-induced LH pulse amplitude [Hours 8-11]

      Amplitude of LH pulse in response to kisspeptin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Stephanie B. Seminara, MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT05901467
    Other Study ID Numbers:
    • 326733
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 13, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital
    reproductive disorders
    kisspeptin
    infertility
    Additional relevant MeSH terms:
    Hormones

    Study Results

    No Results Posted as of Jun 13, 2023