Effects of Seminal Plasma on Pregnancy Rate With IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2023-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

seminal plasma

Intervention Type BIOLOGICAL

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

Group Type PLACEBO_COMPARATOR

Physiological NaCL solution

Intervention Type BIOLOGICAL

Interventions

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seminal plasma

Intervention Type BIOLOGICAL

Physiological NaCL solution

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No