Healthy RelatedNCT03991663
Azoospermia Patients
An observational study of Healthy Related, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Healthy Related
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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；
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhiqin Bu, M.D., 15981978863, rmczzu@126.com
About this study
Official title: Prospective Cohort Study for Azoospermia Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
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.
- Conditions
- Healthy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of serum FSH (Follicle stimulation hormone)
mIU/mL
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Level of serum LH (luteinizing hormone)
mIU/mL
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Level of serum T (Testosterone)
ng/ml
Measured: 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
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991663
- Sponsor's protocol ID
- RMCZZU-azoospermia cohort
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29259430Deruyver 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study for Azoospermia Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
- ClinicalTrials.gov ID
- NCT03991663
- Acronym / sponsor ID
- RMCZZU-azoospermia cohort
- Conditions
- Healthy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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；
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of serum FSH (Follicle stimulation hormone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
mIU/mL
Level of serum LH (luteinizing hormone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
mIU/mL
Level of serum T (Testosterone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
ng/ml
1 secondary outcome
Volume of testicles
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Background: PubMed 29259430Enatsu 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.
- Background: PubMed 24193894Deruyver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Related, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lanlan Fang, M.D. (13673355291, fanglly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of serum FSH (Follicle stimulation hormone) (time frame: From date of inclusion, assessed by each 12 month, up to 40 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.