Clinical trial NCT03991663: Azoospermia Patients
Official title: Prospective Cohort Study for Azoospermia Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Related
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 10000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Level of serum FSH (Follicle stimulation hormone)
timeFrame: From date of inclusion, assessed by each 12 month, up to 40 years
measure: Level of serum LH (luteinizing hormone)
timeFrame: From date of inclusion, assessed by each 12 month, up to 40 years
measure: Level of serum T (Testosterone)
timeFrame: From date of inclusion, assessed by each 12 month, up to 40 years
Secondary outcomes:
measure: Volume of testicles
timeFrame: From date of inclusion, assessed by each 12 month, up to 40 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
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.
citation: 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.