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Trial record 80 of 415 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

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.

Condition or disease Intervention/treatment Phase
Azoospermia Drug: GnRHa/ hCG/ hMG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hormonal profile [ Time Frame: 9 months ]
    Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Bing Yao, MD 86-25-80860174 yaobing@nju.edu.cn

Locations
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China, Jiangsu
Center for Reproductive Medicine, Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Bing Yao, MD    86-25-80860174    yaobing@nju.edu.cn   
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Bing Yao, MD Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bing Yao, Director of Center for Reproductive Medicine, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02544191     History of Changes
Other Study ID Numbers: AzoospermiaNanjing
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016
Keywords provided by Bing Yao, Jinling Hospital, China:
azoospermia nonobstructive
male infertility
Additional relevant MeSH terms:
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Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male
Goserelin
Chorionic Gonadotropin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Reproductive Control Agents
Physiological Effects of Drugs