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

Phase 2

• Conditions: Azoospermia
• Interventions: Drug: GnRHa/ hCG/ hMG

• Registration Number: NCT02544191
• Lead Sponsor: Jinling Hospital, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-29
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Study Start: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GnRHa/ hCG/ hMG	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.

Primary Outcome Measures

Name	Time	Method
Sperm retrieval rate (SRR)	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Hormonal profile	9 months	Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.

Trial Locations

Locations (1)

Center for Reproductive Medicine, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China