Reproductive DisorderPhase 1NCT05901467

Recall by Genotype: Neuropeptide Stimulation

A Phase 1 study testing kisspeptin 112-121 and GnRH in people with Reproductive Disorder, run by Stephanie B. Seminara, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Reproductive Disorder
What is being tested?: kisspeptin 112-121 and GnRH
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2023to 29 May 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the 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

Conditions: Reproductive Disorder
Being tested: kisspeptin 112-121, GnRH
Keywords: reproductive disorders, kisspeptin, infertility, GnRH
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

kisspeptin 112-121Drug
Also called metastin 45-54
One IV bolus of kisspeptin 112-121
GnRHDrug
Also called gonadotropin-releasing hormone
One IV bolus of gonadotropin-releasing hormone

Study groups in NCT05901467
Study group	Role	What they receive
kisspeptin, GnRH	Experimental	IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus. Receives: Drug: kisspeptin 112-121; Drug: GnRH

What is being measured

The primary outcome is the main question the study is designed to answer.

Endogenous LH Pulse Amplitude
Average amplitude of LH pulses at baseline
Measured: Hours 0-8
Kisspeptin-induced LH Pulse Amplitude
Amplitude of LH pulse in response to kisspeptin
Measured: Hours 8-11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202329 May 2024

First posted13 Jun 2023
Study start20 Oct 2023
Primary completion29 May 2024
Study completion29 May 2024

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Reproductive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901467
Sponsor's protocol ID: 326733
Other IDs: P50HD104224
Status last verified: Nov 2025
First submitted: 31 May 2023
Last updated: 6 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Active, not recruiting
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm

All Reproductive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Recall by Genotype: Neuropeptide Stimulation
ClinicalTrials.gov ID: NCT05901467
Acronym / sponsor ID: 326733
Conditions: Reproductive Disorder
Keywords: reproductive disorders, kisspeptin, infertility, GnRH
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 16 participants (actual)
Lead sponsor: Stephanie B. Seminara, MDUniversity, hospital or other
Study start: 20 Oct 2023 (actual)
Primary completion: 29 May 2024 (actual)
Study completion: 29 May 2024 (actual)
First posted: 13 Jun 2023 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
kisspeptin, GnRH	Experimental	Drug: kisspeptin 112-121, Drug: GnRHIV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

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)

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
kisspeptin 112-121Also: metastin 45-54One IV bolus of kisspeptin 112-121	Drug	kisspeptin, GnRH
GnRHAlso: gonadotropin-releasing hormoneOne IV bolus of gonadotropin-releasing hormone	Drug	kisspeptin, GnRH

Primary outcome

Endogenous LH Pulse Amplitude
Time frame: Hours 0-8
Average amplitude of LH pulses at baseline
Kisspeptin-induced LH Pulse Amplitude
Time frame: Hours 8-11
Amplitude of LH pulse in response to kisspeptin

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Kisspeptin, GnRH	16	0

Primary outcome: Endogenous LH Pulse Amplitude

Time frame: Hours 0-8. Mean (Standard Deviation). Unit: mIU/mL

Population analysed: No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Primary outcome: Kisspeptin-induced LH Pulse Amplitude

Time frame: Hours 8-11. Mean (Standard Deviation). Unit: mIU/mL

Population analysed: No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Adverse events

Time frame: From time of study consent until removal from study participation (approximately 2 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Kisspeptin, GnRH	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16

Limitations and caveats (from the sponsor): No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Reproductive Disorder

RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Active, not recruiting
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie B Seminara, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing kisspeptin 112-121 and GnRH in people with Reproductive Disorder, run by Stephanie B. Seminara, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endogenous LH Pulse Amplitude (time frame: Hours 0-8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.