Effects of Seminal Plasma on Pregnancy Rate With IVF
SENAVA
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?
1 other identifier
interventional
1,600
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedOctober 2, 2023
September 1, 2023
6.3 years
March 17, 2016
September 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rate
Pregnancy as a viable fetus at ultrasonography around week 12 and delivery of baby
40 weeks
Secondary Outcomes (1)
Cytokine content
40 weeks
Study Arms (2)
Seminal plasma
EXPERIMENTALHalf 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 COMPARATORAn 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
Interventions
Eligibility Criteria
You may qualify if:
- subjects have given informed consent
- infertility for at least 1 year
- the couple wishing IVF
- subjects aged between 20 - 40 years
- azoospermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ostergotland County Council, Swedenlead
- Linkoeping Universitycollaborator
Study Sites (1)
University Hospital
Linköping, 581 85, Sweden
Related Publications (1)
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.
PMID: 38342372DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Nedstrand, PhD, Md
Ostergotland County Council, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 23, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share