NCT03033563

Brief Summary

The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

January 21, 2017

Last Update Submit

January 24, 2017

Conditions

Intracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

  • Intracytoplasmic sperm injection outcome

    Pregnancy rate.

    three years

Study Arms (1)

Testicular tissue versus ejaculate

Evaluation of ICSI outcome.

Procedure: Intracytoplasmic sperm injection

Interventions

Intracytoplasmic sperm injectionPROCEDURE

Intracytoplasmic sperm injection

Testicular tissue versus ejaculate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile couples

You may qualify if:

  • Couples seeking ICSI.

You may not qualify if:

  • Couples not seeking ICSI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ahmad Raef

Study Record Dates

First Submitted

January 21, 2017

First Posted

January 27, 2017

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 31, 2014

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share