Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT05901467
Status:
TERMINATED
Last Update Posted:
2025-11-18
First Post:
2023-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recall by Genotype: Neuropeptide Stimulation
Sponsor:
Stephanie B. Seminara, MD
Organization:
Study Overview
Official Title:
Recall by Genotype: Neuropeptide Stimulation
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50HD104224 | NIH | None | https://reporter.nih.gov/quic… | View |