Recall by Genotype: Neuropeptide Stimulation

Phase 1

Terminated

• Conditions: Reproductive Disorder
• Interventions: Drug: kisspeptin 112-121; Drug: GnRH

• Registration Number: NCT05901467
• Lead Sponsor: Stephanie B. Seminara, MD

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.

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 Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-13
• Study Start: 2023-10-20
• Status Verified: 2024-05
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kisspeptin, GnRH	kisspeptin 112-121	IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
kisspeptin, GnRH	GnRH	IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.

Primary Outcome Measures

Name	Time	Method
Endogenous LH pulse amplitude	Hours 0-8	Average amplitude of LH pulses at baseline
Kisspeptin-induced LH pulse amplitude	Hours 8-11	Amplitude of LH pulse in response to kisspeptin

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States