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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility

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