Insulin ResistanceNCT01509482
Insulin Resistance in Idiopathic Oligospermia and Azoospermia
A study testing blood samples in people with Insulin Resistance and Oligospermia, run by The Egyptian IVF-ET Center at 1 site in Egypt.
Trial summary
Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Oligospermia, Azoospermia
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- sperm count less than 10 million per milliliter
- non-obstructive azoospermia
Who cannot join
- high FSH ( > 10 mIU/ ml )
- high prolactin ( > 36 mIU/ml )
- abnormal karyotype
- AZF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia
Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.
Read the detailed description
During the past decade IR has been recognized as a major contributor to the pathogenesis of chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS . Theoretically IR in men may result in a similar reproductive abnormalities ( chronic hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in PCOS in women .
- Conditions
- Insulin Resistance, Oligospermia, Azoospermia
- Being tested
- blood samples
- Keywords
- insulin resistance, unexplained azoospermia, unexplained oligospermia
- Medical subject headings
- Insulin Resistance, Oligospermia, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
Also called Unexplained oligospermia and azoospermia
blood samples to test for primary and secondary outcome measures
Blood samplesOther
Also called Hypospermatogenesis
IR Cholesterol HDL LDL Fasting Glucose Triglycerides
| Study group | Role | What they receive |
|---|---|---|
| insulin resistance | Experimental | unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis. Receives: Other: blood samples |
| Fertile males | Active comparator | Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum insulin
Measured: one month
Secondary outcomes (6)
Fasting Glucose
Measured: one month
cholesterol
Measured: one month
high density lipoprotein ( HDL)
Measured: one month
Low density lipoprotein ( LDL )
Measured: one month
testosterone
Measured: one month
Triglycerides
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Egyptian IVF-ET Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaa Mansour, The Egyptian IVF-ET Center
- Investigators
- Ragaa Mansour, MD,PhD, Principal investigator, The Egyptian IVF-ET Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509482
- Sponsor's protocol ID
- insulin resistance
- Status last verified
- Nov 2014
- First submitted
- 6 Jan 2012
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT01509482
- Acronym / sponsor ID
- insulin resistance
- Conditions
- Insulin Resistance, Oligospermia, Azoospermia
- Keywords
- insulin resistance, unexplained azoospermia, unexplained oligospermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Egyptian IVF-ET CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jan 2012 (estimated)
- 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.
Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.
Detailed description
During the past decade IR has been recognized as a major contributor to the pathogenesis of chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS . Theoretically IR in men may result in a similar reproductive abnormalities ( chronic hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in PCOS in women .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin resistance | Experimental | Other: blood samplesunexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis. |
| Fertile males | Active comparator | Other: Blood samplesHealthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sperm count less than 10 million per milliliter
- non-obstructive azoospermia
Key exclusion criteria (4 listed)
- high FSH ( > 10 mIU/ ml )
- high prolactin ( > 36 mIU/ml )
- abnormal karyotype
- AZF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesAlso: Unexplained oligospermia and azoospermiablood samples to test for primary and secondary outcome measures | Other | insulin resistance |
| Blood samplesAlso: HypospermatogenesisIR Cholesterol HDL LDL Fasting Glucose Triglycerides | Other | Fertile males |
Primary outcome
serum insulin
Time frame: one month
6 secondary outcomes
Fasting Glucose
Time frame: one month
cholesterol
Time frame: one month
high density lipoprotein ( HDL)
Time frame: one month
Low density lipoprotein ( LDL )
Time frame: one month
testosterone
Time frame: one month
Triglycerides
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
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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. This study is not recruiting at the moment.
Ragaa Mansour, MD,PhD principal investigator
The Egyptian IVF-ET Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Insulin Resistance and Oligospermia, run by The Egyptian IVF-ET Center at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 2014. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum insulin (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2014.