Azoospermia Patients

Healthy Related Clinical Trial

Official title:

Prospective Cohort Study for Azoospermia Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991663
• Other study ID #: RMCZZU-azoospermia cohort
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: December 31, 2050

Study information

• Verified date: June 2019
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Lanlan Fang, M.D.
• Phone: 13673355291
• Email: fanglly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Prospective Cohort Study for Azoospermia Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Description:

Infertility is an important problem with a multifactorial etiology that affects approximately 15% of couples who attempt pregnancy. Its cause in approximately 50% of infertile couples is male factors. Spermatogenesis is an extremely complex cell differentiation process involving 2,300 genes that regulate germ cell development and maturation.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit azoospermia participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for azoospermia prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• at least three semen evaluations performed on separate occasions, when the seminal specimen after centrifugation showed no sperm under the microscope and was then diagnosed according to several clinical parameters;

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Azoospermia
• Healthy Related

Locations

Country	Name	City	State
China	Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (2)

Deruyver Y, Vanderschueren D, Van der Aa F. Outcome of microdissection TESE compared with conventional TESE in non-obstructive azoospermia: a systematic review. Andrology. 2014 Jan;2(1):20-4. doi: 10.1111/j.2047-2927.2013.00148.x. Epub 2013 Nov 6. Review. — View Citation

Enatsu N, Chiba K, Fujisawa M. The development of surgical sperm extraction and new challenges to improve the outcome. Reprod Med Biol. 2015 Nov 27;15(3):137-144. doi: 10.1007/s12522-015-0228-2. eCollection 2016 Jul. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of serum FSH (Follicle stimulation hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Primary	Level of serum LH (luteinizing hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Primary	Level of serum T (Testosterone)	ng/ml	From date of inclusion, assessed by each 12 month, up to 40 years
Secondary	Volume of testicles	Record the Length (mm)*Width (mm) of each testicle	From date of inclusion, assessed by each 12 month, up to 40 years