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

Primary Purpose

Azoospermia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
GnRHa/ hCG/ hMG
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Azoospermia focused on measuring azoospermia nonobstructive, male infertility

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Reproductive Medicine, Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GnRHa/ hCG/ hMG

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2015
Last Updated
August 1, 2016
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02544191
Brief Title
GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia
Official Title
GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia
Keywords
azoospermia nonobstructive, male infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRHa/ hCG/ hMG
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
GnRHa/ hCG/ hMG
Other Intervention Name(s)
Goserelin/ Pregnyl/ Urofollitropin for Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sperm retrieval rate (SRR)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Hormonal profile
Description
Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.
Time Frame
9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Yao, MD
Phone
86-25-80860174
Email
yaobing@nju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Yao, MD
Organizational Affiliation
Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Center for Reproductive Medicine, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Yao, MD
Phone
86-25-80860174
Email
yaobing@nju.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
30243299
Citation
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.
Results Reference
derived

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

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