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| ID | Type | Description | Link |
|---|---|---|---|
| P50HD104224 | U.S. NIH Grant/Contract | View source |
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The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kisspeptin, GnRH | Experimental | IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kisspeptin 112-121 | Drug | One IV bolus of kisspeptin 112-121 |
|
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie B Seminara, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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There was no washout or run-in period. 4 individuals were found to be ineligible by criteria.
Boston area. 16 participants were consented and screened for eligibility between 10/2023 and 4/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kisspeptin, GnRH | IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kisspeptin, GnRH | IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endogenous LH Pulse Amplitude | Average amplitude of LH pulses at baseline | No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs. | Posted | Mean | Standard Deviation | mIU/mL | Hours 0-8 |
|
|
From time of study consent until removal from study participation (approximately 2 months).
All participants were asked about new health symptoms at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kisspeptin, GnRH | IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment | The primary healthcare team of the participant informed the study team of this adverse event. The event was determined to be grade 1 and unrelated to study interventions. |
No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Seminara | Massachusetts General Hospital | 617-726-1309 | MGHKisspeptinResearch@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2025 | Oct 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2023 | Feb 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| GnRH | Drug | One IV bolus of gonadotropin-releasing hormone |
|
|
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Age, Categorical | Count of Participants | Participants |
|
| Primary | Kisspeptin-induced LH Pulse Amplitude | Amplitude of LH pulse in response to kisspeptin | No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs. | Posted | Mean | Standard Deviation | mIU/mL | Hours 8-11 |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |