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

Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544191
• Other study ID #: AzoospermiaNanjing
• Status: Recruiting
• Phase: Phase 2
• First received: August 29, 2015
• Last updated: August 1, 2016
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Jinling Hospital, China
• Contact: Bing Yao, MD
• Phone: 86-25-80860174
• Email: yaobing[@]nju.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Center for Reproductive Medicine, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Hormonal profile	Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.	9 months	No