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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
seminal plasma
Physiological NaCL solution
Sponsored by
Ostergotland County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Seminal plasma

Physiological NaCL solution

Arm Description

Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening

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

Outcomes

Primary Outcome Measures

Pregnancy rate
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby

Secondary Outcome Measures

Cytokine content
the amount of cytokines in seminal plasma used for deposition around the external cervical opening

Full Information

First Posted
March 17, 2016
Last Updated
September 29, 2023
Sponsor
Ostergotland County Council, Sweden
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02716753
Brief Title
Effects of Seminal Plasma on Pregnancy Rate With IVF
Acronym
SENAVA
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?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
March 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostergotland County Council, Sweden
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seminal plasma
Arm Type
Experimental
Arm Description
Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening
Arm Title
Physiological NaCL solution
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
seminal plasma
Intervention Type
Biological
Intervention Name(s)
Physiological NaCL solution
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Cytokine content
Description
the amount of cytokines in seminal plasma used for deposition around the external cervical opening
Time Frame
40 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Nedstrand, PhD, Md
Organizational Affiliation
Ostergotland County Council, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Seminal Plasma on Pregnancy Rate With IVF

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