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Proposed Research Protocol For Male Infertility

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE December 6, 2010
First Posted Date  ICMJE December 7, 2010
Last Update Posted Date December 7, 2010
Study Start Date  ICMJE January 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proposed Research Protocol For Male Infertility
Official Title  ICMJE Proposed Research Protocol For Male Infertility
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Male Infertility
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Male Infertility Protocol
Intervention: Procedure: Male Infertility Protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December¬†6,¬†2010)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01255397
Other Study ID Numbers  ICMJE MF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Amir Weiss, HaEmek Medical Center
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account HaEmek Medical Center, Israel
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP