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NCT02716753 Clinical Trial

Effects of Seminal Plasma on Pregnancy Rate With IVF

Infertility Clinical Trial

— 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?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02716753
Other study ID # Dno 2015/387-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date March 2023

Study information
Verified date September 2023
Source Ostergotland County Council, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1600
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• seminal plasma

• Physiological NaCL solution

Locations
Country Name City State
Sweden University Hospital Linköping

Sponsors (2)
Lead Sponsor Collaborator
Ostergotland County Council, Sweden Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby 40 weeks
Secondary Cytokine content the amount of cytokines in seminal plasma used for deposition around the external cervical opening 40 weeks
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