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

Study Overview
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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.

Official Title
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GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China

Conditions
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Azoospermia

Intervention / Treatment
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* Drug: GnRHa/ hCG/ hMG


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRHa/ hCG/ hMG<br>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. | Drug: GnRHa/ hCG/ hMG<br>* 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.<br>* Other names: Goserelin/ Pregnyl/ Urofollitropin for Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm retrieval rate (SRR) | Semen analysis was performed every month from the end of the 6th month (two months after the last injection of hMG) to the end of 9th month until any sperm was found in the semen. If not sperm was found at the end of the 9th month, testicular sperm aspiration(TESA) was performed and the tissue was used for histological assessment. If any sperm was found in the semen analysis or TESA, the treatment was effective. The sperm retrieval rate was calculated. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal profile | Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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azoospermia nonobstructive, male infertility