InfertilitySENAVANCT02716753
Effects of Seminal Plasma on Pregnancy Rate With IVF
A study testing seminal plasma and Physiological NaCL solution in people with Infertility, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- seminal plasma and Physiological NaCL solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subjects have given informed consent
- infertility for at least 1 year
- the couple wishing IVF
- subjects aged between 20 - 40 years
Who cannot join
- azoospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- seminal plasma, Physiological NaCL solution
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seminal plasmaBiological
Physiological NaCL solutionBiological
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: seminal plasma |
| 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 Receives: Biological: Physiological NaCL solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
Measured: 40 weeks
Secondary outcomes (1)
Cytokine content
the amount of cytokines in seminal plasma used for deposition around the external cervical opening
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2023
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Elizabeth Nedstrand, Ostergotland County Council, Sweden
- Investigators
- Elizabeth Nedstrand, PhD, Md, Principal investigator, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716753
- Sponsor's protocol ID
- Dno 2015/387-31
- Acronym
- SENAVA
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2016
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38342372
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT02716753
- Acronym / sponsor ID
- SENAVA / Dno 2015/387-31
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seminal plasma | Experimental | Biological: seminal plasmaHalf 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 | Biological: Physiological NaCL solutionAn 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- subjects have given informed consent
- infertility for at least 1 year
- the couple wishing IVF
- subjects aged between 20 - 40 years
Key exclusion criteria (1 listed)
- azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seminal plasma | Biological | Seminal plasma |
| Physiological NaCL solution | Biological | Physiological NaCL solution |
Primary outcome
Pregnancy rate
Time frame: 40 weeks
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
1 secondary outcome
Cytokine content
Time frame: 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 38342372Liffner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Nedstrand, PhD, Md principal investigator
Ostergotland County Council, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seminal plasma and Physiological NaCL solution in people with Infertility, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.