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The Value of HBA in the Evaluation of Idiopathic Infertility

The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01683435
Enrollment
35
Registered
2012-09-11
Start date
2011-11-30
Completion date
2012-01-31
Last updated
2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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

Detailed description

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 We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate

Interventions

OTHERHBA binding assay

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

Sponsors

St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups 1. 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 2. 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 3. Tubal infertility as assessed by HSG or laparoscopy

Exclusion criteria

* women over 40, prior failed IVF

Design outcomes

Primary

MeasureTime frame
In each of these groups we will assess presence of HBA bound spermimmediate at time of preforming HBA test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026