Effects of Seminal Plasma on Pregnancy Rate With IVF (SENAVA)

Ostergotland County Council, Sweden

Status: Completed

Conditions: Infertility

Treatments: Biological: Physiological NaCL solution; Biological: seminal plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02716753

Dno 2015/387-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,600 participants in 2 patient groups, including a placebo group

Seminal plasma

Experimental group

Description:

Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening

Treatment:

Biological: seminal plasma

Physiological NaCL solution

Placebo Comparator group

Description:

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

Treatment:

Biological: Physiological NaCL solution