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

September 29, 2023 updated by: Elizabeth Nedstrand, Ostergotland County Council, Sweden

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

Completed

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

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 581 85
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Ostergotland County Council, Sweden

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Elizabeth Nedstrand, PhD, Md, Ostergotland County Council, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimated)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

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)?

NO

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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