GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia

Jinling Hospital, China

Status and phase: Unknown; Phase 2

Conditions: Azoospermia

Treatments: Drug: GnRHa/ hCG/ hMG

Study type: Interventional

Funder types: Other

Identifiers

NCT02544191

AzoospermiaNanjing

Details and patient eligibility

About

Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA. It was generally believed that gonadotrophin treatment would be ineffective in the presence of high plasma levels of endogenous gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal gonadotropin) are effective in the treatment of non-obstructive azoospermia.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects aged 18-45 with clinical diagnosis of non-obstructive azoospermia.
• At least testicular volume more than 8.0ml on one side .
• FSH more than 5.5 IU/L.

Exclusion criteria

• Subjects with anatomical abnormalities of the genital tract.
• allergy to the drugs used for treatment.
• Y chromosome deletions or abnormal karyotypes.
• Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

GnRHa/ hCG/ hMG

Experimental group

Description:

3.6mg GnRHa (Goserelin, AstraZeneca UK Limited) every 28days for 5 months. After 2 months from the first Goserelin injection, all subjects were treated with hCG (Pregnyl, N.V. Organon Oss,Holland ) at a dose of 2000 IU once a week for 3 months. After 3 months from the first Goserelin injection, all subjects were treated with hMG (Urofollitropin for Injection, Livzon Pharm Group Inc., China) at a dose of 150 IU every 3 days for 2 months.

Treatment:

Drug: GnRHa/ hCG/ hMG