Recall by Genotype: Neuropeptide Stimulation

Study Overview
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Brief Summary
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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
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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

Official Title
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Recall by Genotype: Neuropeptide Stimulation

Conditions
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Reproductive Disorder

Intervention / Treatment
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* Drug: kisspeptin 112-121
* Drug: GnRH


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kisspeptin, GnRH<br>IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. | Drug: kisspeptin 112-121<br>* One IV bolus of kisspeptin 112-121<br>* Other names: metastin 45-54;Drug: GnRH<br>* One IV bolus of gonadotropin-releasing hormone<br>* Other names: gonadotropin-releasing hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproductive disorders, kisspeptin, infertility, GnRH