Sequential Therapy for Hypogonadotropic Hypogonadism (NCT01403532) | Clinical Trial Compass
CompletedPhase 4
Sequential Therapy for Hypogonadotropic Hypogonadism
China100 participantsStarted 2009-09
Plain-language summary
The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.
Who can participate
Age range
16 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical hypogonadotropic hypogonadism
* Hormonal levels: Testosterone \< 1.8ng/ml, LH \< 2-3 mIU/mL and FSH \< 2-3 mIU/mL
* Infantile testis
* Delayed bone age
* Normal testing of the anterior pituitary gland
Exclusion Criteria:
* Prior therapy with HMG or FSH
* Severe dysfunction of live and kidney
* Cryptorchidism or no response to HCG stimulation experiment (Testosterone \< 1.8ng/ml after HCG stimulation)
* Another pituitary hormonal deficiency
* Hypergonadotropic hypogonadism
* With abnormal karyotype
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Sperm density ≥1,000,000/ml
Timeframe: One and a half year
Trial details
NCT IDNCT01403532
SponsorShanghai Jiao Tong University School of Medicine