NCT03353285

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

November 21, 2017

Last Update Submit

January 17, 2018

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    Number of fertilized eggs per oocyte retrieved

    Day 1 post oocyte retrieval

Secondary Outcomes (3)

  • Maturation rate

    Day of oocyte retrieval

  • Good quality embryos

    Day 2 post oocyte retrieval

  • Blastocyst formation rate

    Day 5 post oocyte retrieval

Study Arms (3)

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

intracytoplasmic sperm injection (ICSI)PROCEDURE

All eggs will be fertilized by ICSI

Group IGroup IIGroup III

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women undergoing IVF treatment

You may qualify if:

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

You may not qualify if:

  • Egg donation
  • PGD cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

RECRUITING

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

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Tryfon G Lainas, Phd

    Eugonia

    STUDY DIRECTOR

Central Study Contacts

Tryfon G Lainas, PhD

CONTACT

00302107236333tlainas@eugonia.com.gr

George T Lainas, MD

CONTACT

00302107236333ggslns@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

November 27, 2017

Primary Completion

January 31, 2018

Study Completion

June 1, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

GR(1)