GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia
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|ClinicalTrials.gov Identifier: NCT02544191|
Recruitment Status : Unknown
Verified August 2016 by Bing Yao, Jinling Hospital, China.
Recruitment status was: Recruiting
First Posted : September 9, 2015
Last Update Posted : August 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Azoospermia||Drug: GnRHa/ hCG/ hMG||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 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.
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.
Other Name: Goserelin/ Pregnyl/ Urofollitropin for Injection
- 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.
- Hormonal profile [ Time Frame: 9 months ]Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544191
|Contact: Bing Yao, MDfirstname.lastname@example.org|
|Center for Reproductive Medicine, Jinling Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Bing Yao, MD 86-25-80860174 email@example.com|
|Study Director:||Bing Yao, MD||Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University|