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Trial record 80 of 423 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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
Sponsor:
Information provided by (Responsible Party):
Bing Yao, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE August 29, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
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 Measures  ICMJE
 (submitted: September 4, 2015)
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.
Change History Complete list of historical versions of study NCT02544191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
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 Measures  ICMJE
 (submitted: September 4, 2015)
Hormonal profile [ Time Frame: 6 months ]
Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Azoospermia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: GnRHa/ hCG/ hMG
Publications * Hu X, Ding Z, Hong Z, Zou Z, Feng Y, Zhu R, Ma J, Ge X, Li C, Yao B. Spermatogenesis improved by suppressing the high level of endogenous gonadotropins in idiopathic non-obstructive azoospermia: a case control pilot study. Reprod Biol Endocrinol. 2018 Sep 22;16(1):91. doi: 10.1186/s12958-018-0401-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02544191
Other Study ID Numbers  ICMJE AzoospermiaNanjing
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bing Yao, Jinling Hospital, China
Study Sponsor  ICMJE Jinling Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bing Yao, MD Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University
PRS Account Jinling Hospital, China
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP