NCT03354858

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

November 20, 2017

Last Update Submit

July 24, 2018

Conditions

Keywords

follicle flushingdirect follicle aspirationfertilization ratematuration

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).

Procedure: Follicular flushing

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

Follicular flushing

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be born as females and have two ovaries present
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Eugonia

Athens, 11528, Greece

Location

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: 28333185BACKGROUND
  • Franasiak 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: 28276189BACKGROUND
  • Roque 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

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Lainas, PhD

    Eugonia

    STUDY DIRECTOR

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

Locations