To compare Gonadotrophin Dose Regimens for Virilization and Fertility in Male Hypogonadotropic Hypogonadism

A Randomized Controlled Study comparing Combined Low Dose hCG, FSH and Testosterone therapy to Conventional treatment with High Dose hCG and FSH for Induction of Virilization and Fertility in Male Hypogonadotropic Hypogonadism

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025622

Enrollment

Registered

2020-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E230- Hypopituitarism

Interventions

Intervention1: Study Group A: Combination of Low dose hCG (500U thrice per week) plus FSH (150U thrice per week) plus Testosterone Enanthate (100mg biweekly) Control Intervention1: Study Group B: Conv

Eligibility

Inclusion criteria

Inclusion criteria: 1-Male Pre-pubertal HH- Not attained puberty (TV 2-Congenital or acquired pre-pubertal HH

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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) Timepoint: 9 months	—

Countries

India

Contacts

Public ContactDr Nikhil Singhania

PGIMER, Chnadigarh

ramawalia@rediffmail.com9872997438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026