Recall by Genotype: Neuropeptide Stimulation

NCT05901467 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: 326733P50HD104224
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Disorder

Keywords

reproductive disorders; kisspeptin; infertility; GnRH

Outcome Measures

Primary Outcomes (2)

• Endogenous LH Pulse Amplitude

  Average amplitude of LH pulses at baseline

  Hours 0-8

• Kisspeptin-induced LH Pulse Amplitude

  Amplitude of LH pulse in response to kisspeptin

  Hours 8-11

Study Arms (1)

kisspeptin, GnRH

EXPERIMENTAL

IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.

Drug: kisspeptin 112-121; Drug: GnRH

Interventions

kisspeptin 112-121 DRUG

One IV bolus of kisspeptin 112-121

Also known as: metastin 45-54

kisspeptin, GnRH

GnRH DRUG

One IV bolus of gonadotropin-releasing hormone

Also known as: gonadotropin-releasing hormone

kisspeptin, GnRH

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Results Point of Contact

• Title: Stephanie Seminara
• Organization: Massachusetts General Hospital

MGHKisspeptinResearch@partners.org

617-726-1309

Study Officials

• Stephanie B Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 13, 2023
• Study Start: October 20, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: March 6, 2026
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)