Recall by Genotype: Neuropeptide Stimulation

326733

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.

2023-10-20

2024-05-29

2024-05-29

Terminated

Early phase I

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

2024-06-03