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Effects of Seminal Plasma on Pregnancy Rate With IVF (SENAVA)

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ClinicalTrials.gov Identifier: NCT02716753
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Elizabeth Nedstrand, Ostergotland County Council, Sweden

Brief Summary:

All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina. The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

The success rate will be the number of diagnosed pregnancies and live births.


Condition or disease Intervention/treatment Phase
Infertility Biological: seminal plasma Biological: Physiological NaCL solution Not Applicable

Detailed Description:

All couples planned for IVF will be asked to participate. After information and received informed consent they will be randomized into two groups.

At the time for ovum pick up during an IVF procedure either half of the amount of seminal plasma or the same amount of physiological NaCl solution will be installed around the external cervical opening in vagina.

Normally we do not use the seminal plasma but now half of it will be installed and the other half analysed regarding a number of cytokines possibly involved in the immunological preparation of the female internal genitalia.

The syringe with seminal plasma or physiological NaCl solution will be prepared according to a prearranged randomization list by a technician.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Male Factors on the Success Rate of in Vitro Fertilization. Will Deposition of Seminal Plasma Around the External Cervical os Increase Pregnancy Rate?
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Seminal plasma
Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening
Biological: seminal plasma
Placebo Comparator: Physiological NaCL solution
An amount of physiological NaCL solution equal to half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening
Biological: Physiological NaCL solution



Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 40 weeks ]
    Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby


Secondary Outcome Measures :
  1. Cytokine content [ Time Frame: 40 weeks ]
    the amount of cytokines in seminal plasma used for deposition around the external cervical opening



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • subjects have given informed consent
  • infertility for at least 1 year
  • the couple wishing IVF
  • subjects aged between 20 - 40 years

Exclusion criterion:

  • azoospermia

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): NCT02716753


Contacts
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Contact: Elizabeth Nedstrand, PhD, Md elizabeth.nedstrand@regionostergotland.se
Contact: Susanne Liffner, Md susanne.liffner@regionostergotland.se

Locations
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Sweden
University Hospital Recruiting
Linköping, Sweden, 581 85
Contact: Elizabeth Nedstrand, Md, Phd       elizabeth.nedstrand@regionostergotland.se   
Contact: Susanne Liffner, Md       susanne.liffner@regionostergotland.se   
Sponsors and Collaborators
Ostergotland County Council, Sweden
Linkoeping University
Investigators
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Principal Investigator: Elizabeth Nedstrand, PhD, Md Ostergotland County Council, Sweden
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Responsible Party: Elizabeth Nedstrand, MD, PhD, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT02716753    
Other Study ID Numbers: Dno 2015/387-31
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility