Examination of Idiopathic Hypogonadotropic Hypogonadism (IHH)and Kallmann Syndrome (KS)
United States624 participantsStarted 1989-04
Plain-language summary
The purpose of the study is to examine how Kallmann syndrome (KS) and idiopathic hypogonadotropic hypogonadism (IHH) affect reproductive hormones. These disorders are caused by a defect in Gonadotropin Releasing Hormone (GnRH) secretion. GnRH is a hormone released by a small gland in the brain called the hypothalamus. When GnRH is released, it signals another gland in the brain, the pituitary, to secrete the reproductive hormones that influence sex hormone (testosterone, estrogen) levels and gamete (sperm, egg cell) production.
This study involves a detailed evaluation and 24-48 hours stay at the hospital.
In this study, males and females ages 16 and older with IHH have a detailed evaluation which involves an overnight study at the hospital. Some men (18 years and older) may continue on to receive treatment with pulsatile GnRH. This treatment replaces the hormone which is absent in IHH and results in normalized testosterone and typically is effective in developing fertility.
Who can participate
Age range
16 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility
Ages Eligible for Study:
* Adolescents (16-17yrs)
* Adults (18 years and older)
* Genders Eligible for Study:
* Male and Female
* Accepts Healthy Volunteers:
* No
Criteria
Inclusion Criteria:
* adolescent boys (age 16-17 years) and adult male individuals (age 18 years and older) with a single serum sample demonstrating low testosterone in association with low or inappropriately normal gonadotropin levels
* adolescent girls (age 16-17 years) and adult female individuals (age 18 years and older) with a single serum sample demonstrating low estradiol (estrogen) in association with low or inappropriately normal gonadotropin levels
* suitable male and female hypogonadotropic hypogonadal subjects
Exclusion Criteria:
* no specific exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, would the findings about endogenous LH secretion patterns in IHH and Kallmann Syndrome be relevant to understanding my own diagnosis, and could we review what the results showed?
2This was a Phase 1 study focused on examining LH secretion patterns rather than testing a treatment — does that mean it was primarily about understanding the biology of GnRH deficiency, and how might that kind of research inform the treatment options available to me now?
3Because this trial studied the natural hormone secretion patterns in people with Kallmann Syndrome or IHH, could the insights from it help explain why I'm experiencing specific symptoms, and does it change how you'd approach managing my condition?
4Given that this study is completed and was observational in nature, are there follow-up or treatment-focused trials that came out of this research that might now be worth considering for someone with my diagnosis?
5Since Kallmann Syndrome and idiopathic hypogonadotropic hypogonadism can sometimes be distinguished by smell-related symptoms and other features, did this trial's findings about LH secretion help clarify any differences in how these two conditions should be treated differently?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.