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Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET

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ClinicalTrials.gov Identifier: NCT01809366
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE March 10, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2013)
implantation rate [ Time Frame: 4 weeks after ET ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2013)
  • clinical pregnancy rate [ Time Frame: 4 weeks after ET ]
  • ongoing pregnancy rate [ Time Frame: 6 weeks after ET ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET
Official Title  ICMJE Not Provided
Brief Summary Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Effect on Implantation and Pregnancy Rates
Intervention  ICMJE Procedure: seminal plasma insemination
Study Arms  ICMJE
  • Experimental: seminal plasma insemination
    seminal plasma insemination
    Intervention: Procedure: seminal plasma insemination
  • Placebo Comparator: culture medium insemination
    culture medium insemination
    Intervention: Procedure: seminal plasma insemination
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2013)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients undergoing oocyte pick up for IVF treatment

Exclusion Criteria:

  • endometriosis
  • low responders
  • uterine malformations
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 41 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809366
Other Study ID Numbers  ICMJE 65/10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assaf Harofeh MC, Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date January 2013

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