NCT03532386

Brief Summary

Infertile men due to oligoasthenospermia with non-tense hydroceles are subjected to ICSI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 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

May 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

May 9, 2018

Last Update Submit

December 9, 2018

Conditions

Infertility, Male

Keywords

Infertilitymale factor infertilityoligoasthenospermiavaginal hydrocele

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    Success of ICSI with positive pregnancy test in serum

    2 weeks after ICSI

Study Arms (2)

Study group

Infertile men with oligoasthenospermia with non-tense vaginal hydrocele subjected to ICSI

Procedure: ICSI

Control group

infertile men with oligoasthenospermia without hydrocele subjected to ICSI

Procedure: ICSI

Interventions

ICSIPROCEDURE

ICSI for both couples

Control groupStudy group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All infertile couples with male factor (oligoasthenospermia) due to non-tense hydrocele

You may qualify if:

  • Infertile couples due to male factor
  • Oligoasthenospermia
  • Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH)
  • Presence or absence of non-tense vaginal hydrocele

You may not qualify if:

  • Presence of varicocele
  • History of recent testicular trauma
  • History of recent or old testicular inflammation
  • Tense vaginal hydrocele
  • Presence of potential female pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

Location

MeSH Terms

Conditions

Infertility, MaleInfertilityTesticular Hydrocele

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesTesticular DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 22, 2018

Study Start

June 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Not accepted to share patient data only results of study to be published

Locations

EG(1)