- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02716753
Effects of Seminal Plasma on Pregnancy Rate With IVF (SENAVA)
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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Nedstrand, PhD, Md
- Email: elizabeth.nedstrand@regionostergotland.se
Study Contact Backup
- Name: Susanne Liffner, Md
- Email: susanne.liffner@regionostergotland.se
Study Locations
-
-
-
Linköping, Sweden, 581 85
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy rate
Time Frame: 40 weeks
|
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
|
40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokine content
Time Frame: 40 weeks
|
the amount of cytokines in seminal plasma used for deposition around the external cervical opening
|
40 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth Nedstrand, PhD, Md, Ostergotland County Council, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dno 2015/387-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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