Effects of Seminal Plasma on Pregnancy Rate With IVF

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Biological: seminal plasma; Biological: Physiological NaCL solution

• Registration Number: NCT02716753
• Lead Sponsor: Ostergotland County Council, Sweden

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.

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Study Start: 2016-11
• Primary Completion: 2023-03
• Study Completion: 2023-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seminal plasma	seminal plasma	Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening
Physiological NaCL solution	Physiological NaCL solution	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

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	40 weeks	Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby

Secondary Outcome Measures

Name	Time	Method
Cytokine content	40 weeks	the amount of cytokines in seminal plasma used for deposition around the external cervical opening

Trial Locations

Locations (1)

University Hospital; 🇸🇪 Linköping, Sweden