NCT01683435

Brief Summary

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

September 7, 2012

Last Update Submit

August 31, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • In each of these groups we will assess presence of HBA bound sperm

    immediate at time of preforming HBA test

Study Arms (1)

hylauronin binding assay

EXPERIMENTAL

HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

Other: HBA binding assay

Interventions

HBA binding assayOTHER

HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

hylauronin binding assay

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups
  • Abnormal Semen Analysis (sperm count \<10 million/ml and /or rapid progressive motility \< 50 %, WHO morphology \<30%) normal HSG , normal ovarian reserve testing and ovulation testing
  • Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH\< 10, AMH\>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
  • Tubal infertility as assessed by HSG or laparoscopy

You may not qualify if:

  • women over 40, prior failed IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Continuum Reproductive Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Martin Keltz, MD

    Mount Sinai St. Luke's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 11, 2012

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

US(1)