To compare Gonadotrophin Dose Regimens for Virilization and Fertility in Male Hypogonadotropic Hypogonadism
Phase 4
- Conditions
- Health Condition 1: E230- Hypopituitarism
- Registration Number
- CTRI/2020/06/025622
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1-Male Pre-pubertal HH- Not attained puberty (TV <4ml and No Secondary Sexual Characters) till 14 years of age.
2-Congenital or acquired pre-pubertal HH
Exclusion Criteria
1-Patients who are not willing to give consent to participate in the study or to undergo
other Investigations.
2-Age less than 14 years
3-Age more than 40 years
4-Post-pubertal or adult onset HH
5-Functional hypogonadism (eating disorder or chronic disease)
6-Testicular disorders (primary hypogonadism)
7-Cryptorchidism
8-Deranged liver functions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Group A (Treatment with Low Dose hCG, FSH and testosterone) is as effective as Group B (Treatment with Conventional High dose hCG and FSH) in inducing spermatogenesis (Sperm Count more than 1 x 10/ml)Timepoint: 3months, 6 months and 9 months
- Secondary Outcome Measures
Name Time Method Change of Testicular Volume from BaselineTimepoint: 9 months;Improvement in Quality of Life (Change in Aging Males Symptom Score from baseline)Timepoint: 9 months;Increase in sperm count from baselineTimepoint: 9 months;Reduction in AMH level from baselineTimepoint: 9 months;Virilization (Change of Ferriman Gallwey Score from Baseline) <br/ ><br>Timepoint: 9 months