Effects of Seminal Plasma on Pregnancy Rate With IVF

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?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02716753

Acronym

SENAVA

Enrollment

1600

Registered

2016-03-23

Start date

2016-11-30

Completion date

2023-03-31

Last updated

2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

BIOLOGICALseminal plasma

BIOLOGICALPhysiological NaCL solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pregnancy rate	40 weeks	Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby

Secondary

Measure	Time frame	Description
Cytokine content	40 weeks	the amount of cytokines in seminal plasma used for deposition around the external cervical opening

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026