Effects of Seminal Plasma on Pregnancy Rate With IVF

Study Overview
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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.

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.

Official Title
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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?

Conditions
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Infertility

Intervention / Treatment
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* Biological: seminal plasma
* Biological: Physiological NaCL solution


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seminal plasma<br>Half of the amount of seminal plasma received after preparation of the spermatozoa used for IVF will be deposited around the external cervical opening | Biological: seminal plasma<br> <br> |
| Placebo Comparator: Physiological NaCL solution<br>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 | Biological: Physiological NaCL solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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