Comparison of two different hormonal regimen for inducing sperm production among patients with congenital hypogonadism.

Efficacy of rFSH Pretreatment Followed by combined rFSH+rHCG versus combined rFSH+rHCG for Inducing Fertility in Congenital Hypogonadotropic Hypogonadism Males: Open Label Pilot RCT - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079074

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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: rFSH pretreatment followed by combination therapy with rFSH and rHCG: 1) Participants in this arm will receive pretreatment with rFSH for 2 months in the dose of 150 U subcutaneously th

0-2 months 1300 U S.C. every third day, later up titrated to 2600 U every third day if normal testosterone is not attained (Normal Testosterone levels (4-11 ng/ml). 4) Further escalation to 3900 U ev

0-2 months 1300 U S.C. every third day. Serum testosterone will be measured at each visit and rHCG dose will be up titrated to 2600 U every third day if normal testosterone is not attained. 4) Further

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years with confirmed diagnosis of severe CHH (defined as absence of puberty with testicular volume less than 4 ml, low serum total testosterone (less than 1ng/ml) with low or inappropriately normal FSH/LH, normal levels of other anterior pituitary hormones and normal MRI scans of the hypothalamic-pituitary region).

Exclusion criteria

Exclusion criteria: 1) Partial hypogonadotropic hypogonadism (testicular volume more than 4 ml) 2) Secondary hypogonadism due to non-congenital causes like pituitary tumors or craniopharyngioma 3) Pre-existing medical conditions affecting sexual development or fertility like thalassemia, cranial irradiation for malignancies etc 4) History of prior gonadotropin/GnRH use 5) Hypergonadotropic hypogonadism 6) Incapability to store and self-administer study drug

Design outcomes

Primary

Measure	Time frame
Acheivement of spermatogenesisTimepoint: Semen analysis will be done on 6, 9, 12 and 15 months	—

Secondary

Measure	Time frame
Testicular volumeTimepoint: Baseline, 2, 4, 6, 9, 12 and 15 months;Sertoli cell function as assessed by AMH and inhibin BTimepoint: Baseline, 6 and 15 months;Serum TestosteroneTimepoint: Baseline, 2, 4, 6, 9, 12 and 15 months	—

Countries

India

Contacts

Public ContactTushar Bandgar

KEM Hospital

chandramail1996@gmail.com8056136747

Outcome results

None listed

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