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RecruitingNCT03991663Updated Jun 19, 2019

Azoospermia Patients

An observational study in Healthy Related, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years to 40 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Healthy Related

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Level of serum FSH (Follicle stimulation hormone)

    mIU/mL

    Time frame: From date of inclusion, assessed by each 12 month, up to 40 years

  2. Level of serum LH (luteinizing hormone)

    mIU/mL

    Time frame: From date of inclusion, assessed by each 12 month, up to 40 years

  3. Level of serum T (Testosterone)

    ng/ml

    Time frame: From date of inclusion, assessed by each 12 month, up to 40 years

Secondary outcomes

  1. Volume of testicles

    Record the Length (mm)\*Width (mm) of each testicle

    Time frame: From date of inclusion, assessed by each 12 month, up to 40 years

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Study locations

1 of 1 sites recruiting
  • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
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References and documents

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. PubMed 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. PubMed 24193894 ↗
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Registry details

Key details

Study ID
NCT03991663
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible party
Yingpu Sun (Director of Reproductive Medical Center, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Jun 19, 2019
Start date
Jan 1, 2010
Primary completion
Dec 31, 2050 (estimated)
Completion
Dec 31, 2050 (estimated)
Last update
Jun 19, 2019

Study contacts

Lanlan Fang, M.D.
Contact
fanglly@163.com
13673355291

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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