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Status unknownNCT03353285Updated Jan 18, 2018

Effect of Follicle Flushing on Oocyte Fertilization Rate

An observational study in Infertility, sponsored by Eugonia. Status unknown at 1 site in Greece. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Eugonia · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment

Read the detailed description

This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment.

Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from:

Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush

development and utilization. Pregnancy rates will be reported as a surrogate outcome.

02

Conditions studied

  • Infertility
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Women undergoing IVF treatment

Inclusion criteria

  • Up to 40 years old
  • Both ovaries present
  • Triggering final oocyte maturation using hCG or GnRH agonist

Exclusion criteria

Exclusion Criteria:

  • Egg donation
  • PGD cases
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group I

    Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing)

    Procedure: intracytoplasmic sperm injection (ICSI)

  • Group II

    Group II= egg retrieved in the 1st-2nd flush

    Procedure: intracytoplasmic sperm injection (ICSI)

  • Group III

    Group III= egg retrieved in the 3rd-5th flush

    Procedure: intracytoplasmic sperm injection (ICSI)

Interventions

  • Procedureintracytoplasmic sperm injection (ICSI)

    All eggs will be fertilized by ICSI

05

What researchers measure

Primary outcomes

  1. Fertilization rate

    Number of fertilized eggs per oocyte retrieved

    Time frame: Day 1 post oocyte retrieval

Secondary outcomes

  1. Maturation rate

    Number of mature (MII) eggs per oocyte retrieved

    Time frame: Day of oocyte retrieval

  2. Good quality embryos

    Number of good quality embryos on Day 2

    Time frame: Day 2 post oocyte retrieval

  3. Blastocyst formation rate

    Number of blastocysts on Day 5 per fertilized egg

    Time frame: Day 5 post oocyte retrieval

06

Study locations

1 of 1 sites recruiting
  • Eugonia
    Athens, 11528, Greece
    Recruiting
07

References and documents

Publications

  • 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. PubMed 28333185 ↗
  • 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. PubMed 28276189 ↗
  • 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. PubMed 23065177 ↗

Individual participant data

Plan to share: Undecided — undecided

08

Registry details

Key details

Study ID
NCT03353285
Lead sponsor
Eugonia
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Nov 27, 2017
Primary completion
Jan 31, 2018 (estimated)
Completion
Jun 1, 2018 (estimated)
Last update
Jan 18, 2018

Study contacts

Tryfon G Lainas, PhD
Contact
tlainas@eugonia.com.gr
00302107236333
George T Lainas, MD
Contact
ggslns@gmail.com
00302107236333
Tryfon G Lainas, Phd
study director · Eugonia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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