NCT02306499

Brief Summary

This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 22, 2014

Last Update Submit

November 30, 2014

Conditions

ICSI AZOOSPERMIA VARICOCELE

Keywords

VARICOCELE-AZOOSPERMIA-ICSI

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.

    6/2014 up to one year.

Secondary Outcomes (3)

  • Fertilization Rate: percentage of fertilized oocyte.

    6/2014 up to one year.

  • Embryo Quality: morphological assessment of the developing embryo.

    6/2014 up to one year.

  • Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.

    6/2014 up to one year.

Study Arms (2)

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE

EXPERIMENTAL

ICSI cases using cryopreserved testicular sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program

Procedure: ICSI

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE

EXPERIMENTAL

ICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele

Procedure: ICSI

Interventions

ICSIPROCEDURE

Intracytoplasmic Sperm Injection

ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELEICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in aى ART program.
  • ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.

You may not qualify if:

  • Cases with known female factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajyal Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Ramadan Saleh, MD

    Sohag University

    STUDY DIRECTOR

  • Reham Ezz-Eldawla, MD

    Sohag University

    STUDY DIRECTOR

  • Mohamed Yahya, MD

    Sohag University

    STUDY DIRECTOR

  • Muhammed Fawzy

    Ibn Sina Hospital

    STUDY DIRECTOR

Central Study Contacts

Mohamed Alhussini, M.B.B.Ch.

CONTACT

00201005817574drhussini@yahoo.com

Ramadan Saleh, MD

CONTACT

00201005423054salehr2010@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Egypt - Sohag - Nasser City - Sohag University - Faculty Of Medicine - Dermatology, Venereology and Andrology Department

Study Record Dates

First Submitted

November 22, 2014

First Posted

December 3, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

December 3, 2014

Record last verified: 2014-11

Locations

EG(1)