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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

Brief Summary:
Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.

Condition or disease Intervention/treatment Phase
Effect on Implantation and Pregnancy Rates Procedure: seminal plasma insemination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: seminal plasma insemination
seminal plasma insemination
Procedure: seminal plasma insemination
Placebo Comparator: culture medium insemination
culture medium insemination
Procedure: seminal plasma insemination



Primary Outcome Measures :
  1. implantation rate [ Time Frame: 4 weeks after ET ]

Secondary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 4 weeks after ET ]
  2. ongoing pregnancy rate [ Time Frame: 6 weeks after ET ]


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Ages Eligible for Study:   20 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing oocyte pick up for IVF treatment

Exclusion Criteria:

  • endometriosis
  • low responders
  • uterine malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809366


Locations
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Israel
Infertility and IVF Unit, Assaf harofeh Medical Center
Zrifin, Israel
Sponsors and Collaborators
Assaf-Harofeh Medical Center

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Responsible Party: Assaf Harofeh MC, Senior, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01809366     History of Changes
Other Study ID Numbers: 65/10
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: January 2013

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
seminal plasma/uterine receptivity