The Value of HBA in the Evaluation of Idiopathic Infertility

St. Luke's-Roosevelt Hospital Center

Status: Completed

Conditions: Infertility

Treatments: Other: HBA binding assay

Study type: Interventional

Funder types: Other

Identifiers

NCT01683435

IRB 11-134

Details and patient eligibility

About

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

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

hylauronin binding assay

Experimental group

Description:

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

Treatment:

Other: HBA binding assay