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

NCT02544191 | Unknown Phase 2 DMC

• 1 other identifier: AzoospermiaNanjing
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Azoospermia

Keywords

azoospermia nonobstructive; male infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hormonal profile

  9 months

Study Arms (1)

GnRHa/ hCG/ hMG

EXPERIMENTAL

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

Interventions

GnRHa/ hCG/ hMG DRUG

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.

Also known as: Goserelin/ Pregnyl/ Urofollitropin for Injection

GnRHa/ hCG/ hMG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Center for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30243299 DERIVED

MeSH Terms

Conditions

Azoospermia; Azoospermia, Nonobstructive; Infertility, Male

Interventions

Goserelin; Chorionic Gonadotropin; Urofollitropin; Injections

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins; Placental Hormones; Pregnancy Proteins; Menotropins; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Bing Yao, MD

  Center for Reproductive Medicine, Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

Central Study Contacts

Bing Yao, MD

CONTACT

86-25-80860174; yaobing@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Reproductive Medicine

Study Record Dates

• First Submitted: August 29, 2015
• First Posted: September 9, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 2, 2016

Record last verified: 2016-08

Locations

CN (1)