Hypogonadotropic Hypogonadism
Conditions
Keywords
pituitary stalk interruption syndrome, pulsatile GnRH therapy, hypogonadotropic hypogonadism, hypopituitarism
Brief summary
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
Detailed description
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.
Interventions
DRUGGonadotropin-releasing Hormone
A regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL).
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18 years or over male patients; * Absent or incomplete puberty development; * Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations. * at least two or more pituitary hormone deficiencies * Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.
Exclusion criteria
* cryptorchidism history * other causes of hypopituitarism or severe systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum Luteinizing Hormone(LH) value | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of testicular volume | 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 | 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 | at 3m, 6m, 9m and 12m post treatment | For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment. |
Countries
China
Contacts
Primary ContactXue-yan Wu
Outcome results
None listed