Status:

UNKNOWN

Proposed Research Protocol For Male Infertility

Lead Sponsor:

HaEmek Medical Center, Israel

Conditions:

Male Infertility

Eligibility:

FEMALE

18-30 years

Phase:

NA

Brief Summary

The purpose of this experiment is to test the feasibility of a minimally interventionist protocol for young couples with male factor infertility, which addresses the cause of infertility for these cou...

Eligibility Criteria

Inclusion

  • Couples with "pure" male factor infertility of six months or more, defined as not pregnant in spite of being desirous of pregnancy for at least six months with normal sexual activity and no birth control. Primary and Secondary infertility included.
  • Abnormality of any one of the sperm parameters according to WHO or Kruger for concentration, motility or morphology.
  • Women aged 18 to 30 with a BMI between 18 and 30
  • Women who testify that they are healthy with regular menstrual cycles between 25-35 days per cycle.

Exclusion

  • Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior fertility workup. Paraovarian simple cysts, OK.
  • Prior PID, abdominal or pelvic surgery or abnormal HSG if done.
  • Known allergy to medications used in protocol
  • Diagnosed or suspected genetic or psychiatric disease in either patient.
  • Azoospermia
  • Female partner with a history of infertility with another partner
  • Elevated FSH (over 10 units/L) in female partner if done.

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT01255397

Start Date

January 1 2011

Last Update

December 7 2010

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