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OpenTrials
Completed

NCT Number: NCT02716753

Effects of Seminal Plasma on Pregnancy Rate With IVF

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

seminal plasma

Biological

Physiological NaCL solution

Biological

Primary outcomes

  1. Pregnancy rate

    Time frame: 40 weeks

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

Secondary outcomes

  1. Cytokine content

    Time frame: 40 weeks

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

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Collaborators

  • Linkoeping University

Registry information

Official study 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?

Acronym: SENAVA

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2016
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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