Follicular Flushing Versus Direct Aspiration
Oocyte Recovery Rate Following Follicular Flushing Versus Direct Aspiration in Women Undergoing IVF
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this study is to investigate the impact of follicular flushing on the oocyte recovery rate, oocyte maturity, fertilization rate, and embryo development and utilization as compared to direct aspiration (no flushing) in women undergoing IVF treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
Shorter than P25 for all trials
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
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 26, 2018
July 1, 2018
6 months
November 20, 2017
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oocyte recovery rate
Number of oocytes retrieved per follicle aspirated
Day of oocyte retrieval
Secondary Outcomes (9)
Number of oocytes retrieved
Day of oocyte retrieval
Oocyte maturation rate
Day of oocyte retrieval
Fertilization rate
Day 1 post oocyte retrieval
Good quality embryos on day 2/3
2/3 days post oocyte retrieval
Blastocyst formation rates
Day 5 post oocyte retrieval
- +4 more secondary outcomes
Study Arms (2)
Follicular flushing
One ovary will be aspirated using follicular flushing (up to 5 times per follicle).
No flushing
One ovary will be aspirated using direct aspiration (no flushing).
Interventions
Repeated follicle flushing up to 5 times using a double lumen needle for oocyte recovery
Eligibility Criteria
Women undergoing IVF treatment
You may qualify if:
- Presence of both ovaries
- years old
- Triggering final oocyte maturation using human chorionic gonadotrophin (hCG) or gonadotrophin releasing hormone (GnRH) agonist
You may not qualify if:
- One or no ovaries present
- Endometriosis
- Previous history of hemorrhage during oocyte retrieval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eugonialead
Study Sites (1)
Eugonia
Athens, 11528, Greece
Related Publications (3)
von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.
PMID: 28333185BACKGROUNDFranasiak JM. Follicular flushing: time to look elsewhere to improve in vitro fertilisation outcomes? BJOG. 2017 Jul;124(8):1197. doi: 10.1111/1471-0528.14628. No abstract available.
PMID: 28276189BACKGROUNDRoque M, Sampaio M, Geber S. Follicular flushing during oocyte retrieval: a systematic review and meta-analysis. J Assist Reprod Genet. 2012 Nov;29(11):1249-54. doi: 10.1007/s10815-012-9869-9. Epub 2012 Oct 13.
PMID: 23065177BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lainas, PhD
Eugonia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 28, 2017
Study Start
December 1, 2017
Primary Completion
May 31, 2018
Study Completion
June 1, 2018
Last Updated
July 26, 2018
Record last verified: 2018-07