NCT02021721

Brief Summary

Hypothesis: To identify new gene mutations that can be related to patients with idiopathic male factor infertility. Primary Objective: To detect possible genetic abnormalities in families with more than one sibling with male infertility. Secondary Objective: To evaluate using next generation DNA sequencing in cases of infertility

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

7.7 years

First QC Date

November 22, 2013

Last Update Submit

July 29, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Next generation sequencing

    Use next generation sequencing to discover novel genes

    1 hour

Study Arms (1)

Cohort

Subjects who fulfill the inclusion criteria will be pre-identified by consultation with their attending physicians and by thorough review of the literature to establish that the disease is indeed genetic and unsolved.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with be recruited from HMC infertility clinic.

You may qualify if:

  • The study will include male patients diagnosed with infertility, fitting one of the following categories:
  • More than one family member complaining of male infertility
  • All ethnicities will be included in this study
  • Family members will be invited to join the study

You may not qualify if:

  • Patients in whim infertility is suspected to be caused by environmental factors more than genetic factors
  • Patients whose cause of infertility has already been determined by other clinical testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ronald Crystal, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Haitham El Bardisi, MD

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 27, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

QA(1)