Congenital Hypogonadotropic Hypogonadism
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| The size of the penis before and after treatment;laboratory examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Luteinizing Hormone, LH;Follicle Stimulating Hormone, FSH;testosterone;Inhibin B, INB;Anti-Müllerian Hormone, AMH; | — |
Countries
China
Contacts
Children's hospital of fudan university