Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination
Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes. We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2021
CompletedStudy Start
First participant enrolled
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 3, 2021
January 1, 2021
3 months
January 29, 2021
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks
8 weeks after intrauterine insemination
Study Arms (2)
Washed Catheter
EXPERIMENTALWashed catheter arm: will be washed with culture medium before insemination
Unwashed Catheter
SHAM COMPARATORUnwashed catheter arm: will not be washed with culture medium.
Interventions
The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure
Eligibility Criteria
You may qualify if:
- at least 1-year infertility
- at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy
- ovulatory menstrual cycles
- suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination
You may not qualify if:
- bilateral tubal occlusion
- mild or severe endometriosis
- day 3 serum FSH (follicle-stimulating hormone) \> 13 IU/L
- abnormal thyroid function tests, hyperprolactinemia
- total motile sperm count (TMSC) \< 5 millions or severe teratospermia (\<4% normal forms) following semen preparation
- more than 3 follicles above the size of 17mm on the day of ovulation triggering
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assocciate Professor
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 3, 2021
Study Start
January 29, 2021
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
February 3, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share