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Recruiting NCT03991663

Azoospermia Patients

Observational Healthy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy Related. Basic parameters: 18 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Level of serum FSH (Follicle stimulation hormone) [Time frame: From date of inclusion, assessed by each 12 month, up to 40 years]
  • Level of serum LH (luteinizing hormone) [Time frame: From date of inclusion, assessed by each 12 month, up to 40 years]
  • Level of serum T (Testosterone) [Time frame: From date of inclusion, assessed by each 12 month, up to 40 years]
Secondary outcome measures (1)
  • Volume of testicles [Time frame: From date of inclusion, assessed by each 12 month, up to 40 years]

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University — Zhengzhou

Publications

  • 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. PMID 29259430
  • 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. PMID 24193894

Identifiers

NCT: NCT03991663 · RMCZZU-azoospermia cohort

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗