MedDataX Logo

Insulin Resistance in Idiopathic Oligospermia and Azoospermia

NCT ID: NCT01509482

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Oligospermia Azoospermia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

insulin resistance

unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis.

Group Type EXPERIMENTAL

blood samples

Intervention Type OTHER

blood samples to test for primary and secondary outcome measures

Fertile males

Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis

Group Type ACTIVE_COMPARATOR

Blood samples

Intervention Type OTHER

IR Cholesterol HDL LDL Fasting Glucose Triglycerides

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood samples

blood samples to test for primary and secondary outcome measures

Intervention Type OTHER

Blood samples

IR Cholesterol HDL LDL Fasting Glucose Triglycerides

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Unexplained oligospermia and azoospermia Hypospermatogenesis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* sperm count less than 10 million per milliliter
* non-obstructive azoospermia

Exclusion Criteria

* high FSH ( \> 10 mIU/ ml )
* high prolactin ( \> 36 mIU/ml )
* abnormal karyotype
* AZF
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Egyptian IVF-ET Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ragaa Mansour

Director, the Egyptian IVF-ET center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ragaa Mansour, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Egyptian IVF-ET Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Egyptian IVF-ET center

Cairo, Egypt, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

insulin resistance

Identifier Type: -

Identifier Source: org_study_id