Proposed Research Protocol For Male Infertility

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01255397
• Date of registration: 06/12/2010
• Primary sponsor: HaEmek Medical Center, Israel
• Public title: Proposed Research Protocol For Male Infertility
• Scientific title: Proposed Research Protocol For Male Infertility
• Date of first enrolment: January 2011
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01255397
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Abnormality of any one of the sperm parameters according to WHO or Kruger for
concentration, motility or morphology.

3. Women aged 18 to 30 with a BMI between 18 and 30

4. Women who testify that they are healthy with regular menstrual cycles between 25-35
days per cycle.

Exclusion Criteria:

1. Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior
fertility workup. Paraovarian simple cysts, OK.

2. Prior PID, abdominal or pelvic surgery or abnormal HSG if done.

3. Known allergy to medications used in protocol

4. Diagnosed or suspected genetic or psychiatric disease in either patient.

5. Azoospermia

6. Female partner with a history of infertility with another partner

7. Elevated FSH (over 10 units/L) in female partner if done.



Age minimum: 18 Years
Age maximum: 30 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Male Infertility

Intervention(s)

Procedure: Male Infertility Protocol

Secondary ID(s)

MF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors