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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Azoospermia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRHa/ hCG/ hMG

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.

Group Type EXPERIMENTAL

GnRHa/ hCG/ hMG

Intervention Type DRUG

GnRHa was injected subcutaneously at a dose of 3.6mg every 28 days for 5 months. After 2 months from the first GnRHa injection, all subjects were treated with hCG 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 at a dose of 150 IU every 3 days for 2 months.

Interventions

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GnRHa/ hCG/ hMG

GnRHa was injected subcutaneously at a dose of 3.6mg every 28 days for 5 months. After 2 months from the first GnRHa injection, all subjects were treated with hCG 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 at a dose of 150 IU every 3 days for 2 months.

Intervention Type DRUG

Other Intervention Names

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Goserelin/ Pregnyl/ Urofollitropin for Injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No