Clinical Trial: Reproductive Hormones During Sustained Administration of Kisspeptin

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Placebo-controlled Parallel Design Physiological Study of the Natural Hormone Kisspeptin

Brief Summary: The purpose of this study is to determine the physiological effects of sustained administration of the natural hormone kisspeptin on reproductive function in participants with reduced fertility. Kisspeptin is a recently identified natural hormone which is regulates human reproduction. Learning more about the physiological role of kisspeptins may therefore give us a better understanding about human fertility, and improve the management of patients with reduced fertility. The effects of sustained administration of kisspeptin on hypothalamic reproductive function (i.e. Luteinising hormone pulsatility) are not known.

Detailed Summary: Participants will receive continuous administration of kisspeptin-54 or saline (placebo) for a maximum duration of 3 months, via a portable battery operated pump device.
Sponsor: Imperial College London

Current Primary Outcome: The effect of sustained administration of the hormone kisspeptin on luteinising hormone pulsatility in participants with reduced fertility. [ Time Frame: up to 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine whether there is a difference in luteinising hormone pulsatility between normal fertility participants and reduced fertility participants when given sustained administration of the hormone kisspeptin. [ Time Frame: up to 3 months ]

Original Secondary Outcome: Same as current

Information By: Imperial College London

Dates:
Date Received: February 26, 2014
Date Started: March 2014
Date Completion: February 2019
Last Updated: August 31, 2016
Last Verified: August 2016