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Proposed Research Protocol For Male Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255397
Recruitment Status : Unknown
Verified December 2010 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
Information provided by:
HaEmek Medical Center, Israel

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 couples which is the inability of the sperm to fertilize the egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus on the same day as the aspiration.

Condition or disease Intervention/treatment Phase
Male Infertility Procedure: Male Infertility Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proposed Research Protocol For Male Infertility
Study Start Date : January 2011

Arm Intervention/treatment
Experimental: Male Infertility Protocol Procedure: Male Infertility Protocol
  1. Healthy women with a regular cycle between 28 and 35 days. For the man, an abnormal sperm exam.
  2. Daily US examinations from day 8 of the menstrual cycle. Excluding weekends.
  3. When the leading follicle is 14 mm she will be given 100 units puregon and orgalutran,once daily until the leading follicle is at least 16 mm at which point she will be given ovitrelle at 21:00.
  4. 35 hours after Ovitrelle at 8:00 the husband will present a sperm sample for analysis. A pelvic US will be done to the wife.

    1. If the follicle has collapsed than IUI will be performed
    2. It the total motile sperm count is above 5 million sperm/ml then IUI will be done
    3. If the total motile sperm count is below 5 million and the follicle has not collapsed, proceed to oocyte aspiration and ICSI

6) ICSI and embryo transfer performed on the same day. 7) Luteal support: Endometrin 100 mg twice a day following IUI\ET until 6 weeks gestation Protocol can be repeated for up to 3 cycles per couple.

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Dr. Amir Weiss, HaEmek Medical Center Identifier: NCT01255397    
Other Study ID Numbers: MF-001
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Keywords provided by HaEmek Medical Center, Israel:
male infertility
natural cycle IVF
in-vitro fertilization
intrauterine inseminatio
Additional relevant MeSH terms:
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Infertility, Male