NCT03621995

Brief Summary

The absence of sperms in ejaculated semen, is the most severe form of male-factor infertility and is present in approximately 5 % of all investigated infertile couples.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 20, 2018

Last Update Submit

July 14, 2019

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Measurement of the level of oxidative stress that is caused by cryopreservation of testicular tissue.

    Evaluation of oxidative stress caused by cryopreservation of testicular tissue by measurement of : 1. Catalase activity as one indicator of antioxidants by colorimetric method. 2. Malondialdehyde level as one indicator of lipid peroxidation by colorimetric method.

    3 years

Study Arms (3)

Obstructive azoospermia

Malondialdehyde and Catalase level measurement before and after cryopreservation

Other: Malondialdehyde and Catalase level measurement

Non obstructive azoospermia

Malondialdehyde and Catalase level measurement before and after cryopreservation

Other: Malondialdehyde and Catalase level measurement

Negative group

Malondialdehyde and Catalase level measurement without cryopreservation

Other: Malondialdehyde and Catalase level measurement

Interventions

Malondialdehyde and Catalase level measurementOTHER

Malondialdehyde and Catalase level measurement by colorimetric method

Negative groupNon obstructive azoospermiaObstructive azoospermia

Eligibility Criteria

Age14 Years - 80 Years
Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

45 patients complaining of azoospermia who attended to the Andrology Outpatient Clinic, Dermatology ,Venerology and Andrology department, Assuit University Hospital, Assuit ,Egypt .Patients were divided into 3 groups: * Group A : 15 patients with obustructive azoospermia and positive testicular samples for sperms . * Group B : 15 patients with non obustructive azoospermia and positive testicular samples for sperms. * Group C : 15 patients with azoospermia and negative testicular samples for spems.

You may qualify if:

  • \- Men with azoospermia at reproductive age .

You may not qualify if:

  • Pyospermia.
  • Previous trial of cryopreservation.
  • Systemic diseases.
  • Cryptorchidism history.
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, 71511, Egypt

Location

MeSH Terms

Interventions

Malondialdehyde

Intervention Hierarchy (Ancestors)

AldehydesOrganic Chemicals

Study Officials

  • Aya H Younis, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in dermatology department

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 9, 2018

Study Start

September 10, 2018

Primary Completion

October 10, 2018

Study Completion

November 30, 2018

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

EG(1)