Recall by Genotype: Neuropeptide Stimulation

Stephanie B. Seminara, MD

Status and phase

Terminated

Phase 1

Conditions

Reproductive Disorder

Treatments

Drug: GnRH

Drug: kisspeptin 112-121

Study type

Interventional

Funder types

Other

Identifiers

NCT05901467

326733

P50HD104224 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)