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Subcutaneous injection of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) for the treatment of congenital hypogonadotropic hypogonadism (CHH) in males aged 6 to 24 months: A study on therapeutic efficacy

Subcutaneous injection of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) for the treatment of congenital hypogonadotropic hypogonadism (CHH) in males aged 6 to 24 months: A study on therapeutic efficacy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121261
Enrollment
Unknown
Registered
2026-03-27
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Congenital Hypogonadotropic Hypogonadism

Interventions

control group:None
intervention group:Recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) therapy

Sponsors

Children's hospital of fudan university
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
0.5 Years to 2 Years

Inclusion criteria

Inclusion criteria: 1. Boys aged 6 to 24 months; 2. Meeting the diagnostic criteria for CHH (simultaneously conforming to (a) micropenis and/or cryptorchidism (especially bilateral) and/or hypospadias, and no penile erection. (b) Monitoring that luteinizing hormone (LH) remains less than 1.00 U/L within 3 months after birth. Clinically diagnosing CHH. If only one of (a) and (b) is met, then (c) having a positive family history of CHH, and cleft lip and/or palate or hearing impairment is required; 3. Children evaluated by doctors as having no contraindications to the treatment with recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH); 4. Guardians voluntarily signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with serious diseases such as severe cardiopulmonary diseases, blood system diseases, malignant tumors, diabetes, etc., or those with low immune function; 2. Patients with known highly allergic constitution or those allergic to the drugs used in this research trial; 3. Patients who have participated in other drug clinical trials related to growth and development within the past 3 months; 4. Other situations where the researchers believe that the patients are not suitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
The size of the penis before and after treatment;laboratory examination;

Secondary

MeasureTime frame
Luteinizing Hormone, LH;Follicle Stimulating Hormone, FSH;testosterone;Inhibin B, INB;Anti-Müllerian Hormone, AMH;

Countries

China

Contacts

Public ContactZhangqian Zheng

Children's hospital of fudan university

dr_zhengzhangqian@126.com+86 21 6493 1124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026