Trial · Interventional
Status unknownNot applicableRegistry dataChina
1 trial
Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
NCT02705014Jan 2016 to est. Aug 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
Experimental
treatment group
patients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L.
Outcomes the sponsor listed as primary.
Change of serum Luteinizing Hormone(LH) value
Time frame · Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Change of serum Follicle-Stimulating Hormone (FSH) value
Time frame · Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.
Change of serum total testosterone value
Time frame · Baseline and at 1m,3m, 6m, 9m and 12m post treatment.
Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.
Change of testicular volume
Time frame · Baseline and at 1m,3m, 6m, 9m and 12m post treatment
Testicular volumes are measured using Prader orchidometer. Prader orchidometer is a standard method to measure testicular volume. The normal range of testicular volume of each side in normal adult men is 15-25ml.
Change of sperm counts by routine semen analysis
Time frame · Baseline and at 3m, 6m, 9m and 12m post treatment
if a subject can produce an ejaculate, semen samples are collected by masturbation and analyzed according to the standard World Health Organization method.
the rate of impregnating subject's wife
Time frame · at 3m, 6m, 9m and 12m post treatment
For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Studies that cite this trial.
1 study on this page
Indexing hint: Case report · 2014
Shao et al. 2014Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciencescited by 2
PMID 25131486PUB-25131486
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