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Improving hormonal infertility treatment for men with hypogonadotropic hypogonadism

Improving hormonal treatment for men with infertility due to hypogonadotropic hypogonadism (HHF study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN42591647
Enrollment
300
Registered
2025-04-30
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Infertility due to hypogonadism Nutritional, Metabolic, Endocrine

Interventions

Retrospective study of anonymised data from case notes (obtaining treatment details from patient records without any identifiable information) The researchers will not recruit any participants for t

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult men diagnosed with HH based on the clinical features of hypogonadism, low testosterone, and low gonadotropins 2. Pre-treatment sperm concentration <5 million/mL – congenital and acquired cases will be included 3. Treatment with gonadotrophins between 1995 to 2023 4. Follow-up for at least 2 years or until pregnancy in the partner, whichever is sooner

Exclusion criteria

Exclusion criteria: 1. Concomitant primary hypogonadism 2. Suspicion of reversible aetiology for HH e.g., anabolic steroids, opioids, morbid obesity

Design outcomes

Primary

MeasureTime frame
Reported pregnancy in partner of patient collected from patient records at single timepoint of reported pregnancy

Secondary

MeasureTime frame
1. Time to pregnancy in partner of patient, collected from patient records, at single timepoint of reported pregnancy 2. Use of assisted reproductive technology, collected from patient records, at single timepoint of reported use of ART 3. Appearance of sperm in the semen (in men with baseline azoospermia or inability to produce semen), collected from patient records, at multiple timepoints when semen sample performed (will vary between patients) 4. Sperm concentration >5 million/ml (in men with azoospermia/ inability to produce semen or sperm concentration <5 million/mL), collected from patient records, at multiple timepoints when semen sample performed (will vary between patients) 5. Live birth rates in the partner, collected from patient records at single timepoint of reported live birth 6. Reported adverse effects, collected from patient records at multiple timepoints when adverse effect reported

Countries

England, France, Germany, Italy, Türkiye, United Kingdom, United States of America

Contacts

Public ContactBonnie Grant
b.grant@imperial.ac.uk+44 (0)20 7594 2489

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026