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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seminal plasma | Experimental | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seminal plasma | Biological |
| ||
| Physiological NaCL solution |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine content | the amount of cytokines in seminal plasma used for deposition around the external cervical opening | 40 weeks |
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Inclusion criteria:
Exclusion criterion:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Nedstrand, PhD, Md | Ostergotland County Council, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38342372 | Derived | Liffner S, Bladh M, Rodriguez-Martinez H, Sydsjo G, Zalavary S, Nedstrand E. Intravaginal exposure to seminal plasma after ovum pick-up does not increase live birth rates after in vitro fertilization or intracytoplasmic sperm injection treatment: a double-blind, placebo-controlled randomized trial. Fertil Steril. 2024 Jul;122(1):131-139. doi: 10.1016/j.fertnstert.2024.02.002. Epub 2024 Feb 9. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D012639 | Seeds |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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