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

GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02544191
Enrollment
30
Registered
2015-09-09
Start date
2015-12-31
Completion date
2017-12-31
Last updated
2016-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azoospermia

Keywords

azoospermia nonobstructive, male infertility

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.

Interventions

DRUGGnRHa/ 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.

Sponsors

Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sperm retrieval rate (SRR)4 monthsSemen 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

MeasureTime frameDescription
Hormonal profile9 monthsSerum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.

Countries

China

Contacts

Primary ContactBing Yao, MD
yaobing@nju.edu.cn86-25-80860174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026