What is the effect of the natural occurring hormone kisspeptin on reproductive hormone secretion in humans?

Not Applicable

• Conditions: Conditions that can impair fertility; Not Applicable

• Registration Number: ISRCTN21681316
• Lead Sponsor: Imperial College London

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33196464/ results (added 17/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-17
• Last Update Posted: 11 March 2024
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age over 16 years
2. Ability to give informed consent
3. Adult participants will be recruited with no known problems with reproductive function (normal fertility)
3. Adult participants will be recruited with previous problems with reproductive function (reduced fertility)
4. Availability to attend hospital visits during weekdays for study visits.

Exclusion Criteria

1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the reproductive hormone levels or potentially cause harm to the volunteer
2. Pregnancy or breastfeeding
3. History of hypersensitivity to any of the components of the infusions
4. Treatment with an investigational drug within the preceding 2 months
5. Volunteers who have or intend to donate blood or blood products within three months before or following study completion
6. Volunteers with poor venous access.
7. A history of alcoholism or substance abuse within the preceding 5 years
8. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease
9. A history of cancer
10. Volunteers with a medical or psychological condition that would impair their ability to participate reliably in the study or give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Luteinising hormone (LH) levels measured using chemiluminescent assay over 8hrs<br>2. LH pulsatility measured over 8hrs by blinded deconvolution analysis<br>2. Follicle-stimulating hormone levels measured using chemiluminescent assay over 8hrs

Secondary Outcome Measures

Name	Time	Method
1. Testosterone levels measured using chemiluminescent assay over 8hrs<br>2. Oestrogen levels measured using chemiluminescent assay over 8hrs<br>3. Progesterone levels measured using chemiluminescent assay over 8hrs