To compare the response of triple therapy (hCG, FSH and testosterone) and conventional therapy (hCG and FSH) in male Hypogonadotropic Hypogonadism

A randomized control trial comparing response of hCG, FSH and testosterone therapy and conventional treatment with hCG FSH in male hypogonadotropic hypogonadism

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042795

Enrollment

Registered

2022-05-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

Health Condition 1: E300- Delayed puberty

Interventions

Intervention1: injection hCG, FSH and testosterone enanthate: injection hCG will be given with a starting dose of 2000 IU twice per week with gradual dose incrementation upto 15000 IU per week in two

Eligibility

Inclusion criteria

Inclusion criteria: pre-pubertal hypogonadotropic hypogonadism

Exclusion criteria

Exclusion criteria: 1. Not willing to give consent to participate in the study. 2. Age less than 14 years 3. Functional hypogonadism (eating disorder or chronic disease) 4. Testicular disorders (primary hypogonadism) 5. Previous treatment with gonadotropin 6. Cryptorchidism 7. Deranged liver functions

Design outcomes

Primary

Measure	Time frame
To compare the doses of hCG and FSH required for induction of spermatogenesis in triple (hCG, FSH plus testosterone) therapy and conventional(hCG and FSH) therapyTimepoint: Achievement of primary outcome or till a maximum follow of 18 months, whichever is earlier	—

Secondary

Measure	Time frame
Time to initiation of spermatogenesis The proportion of individuals achieving sperm count more than 10 million/ml To assess improvement in sexual functioning by IIEF-5 or SDI-2 To assess the change in muscle strength by handheld dynamometer Virilization by comparing change of body hair score Improvement in Quality of Life by PDS and qADAM questionnaire Timepoint: Achievement of primary outcome or till a maximum follow of 18 months, whichever is earlier	—

Measure

Time frame

Time to initiation of spermatogenesis The proportion of individuals achieving sperm count more than 10 million/ml To assess improvement in sexual functioning by IIEF-5 or SDI-2 To assess the change in muscle strength by handheld dynamometer Virilization by comparing change of body hair score Improvement in Quality of Life by PDS and qADAM questionnaire Timepoint: Achievement of primary outcome or till a maximum follow of 18 months, whichever is earlier

—

Countries

India

Contacts

Public ContactKonsam Biona Devi

PGIMER, Chandigarh

ramawaliapgimer@gmail.com9872997438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 3, 2026