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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Current Primary Outcome: Sperm retrieval rate (SRR) [ Time Frame: 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.


Original Primary Outcome: Sperm retrieval rate (SRR) [ Time Frame: 3 months ]

Semen analysis before the treatment and every month after the first injection of hCG. If not sperm was found at the end of the treatment, testicular sperm aspiration(TESA) was performed and the tissue was used for histological assessment.


Current Secondary Outcome: Hormonal profile [ Time Frame: 9 months ]

Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.


Original Secondary Outcome: Hormonal profile [ Time Frame: 6 months ]

Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.


Information By: Jinling Hospital, China

Dates:
Date Received: August 29, 2015
Date Started: December 2015
Date Completion: December 2017
Last Updated: August 1, 2016
Last Verified: August 2016