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

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.

Study Overview

• Status: Unknown
• Conditions: Azoospermia
• Intervention / Treatment: Drug: GnRHa/ hCG/ hMG

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Center for Reproductive Medicine, Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Goserelin/ Pregnyl/ Urofollitropin for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormonal profile	Serum FSH, LH, Total Testosterone, inhibin B were measured before the treatment and every month after treatment.	9 months

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Director: Bing Yao, MD, Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 29, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: azoospermia nonobstructive; male infertility
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Azoospermia; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: AzoospermiaNanjing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No