Effect of Follicle Flushing on Oocyte Fertilization Rate

January 17, 2018 updated by: Eugonia
The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: George T Lainas, MD
  • Phone Number: 00302107236333
  • Email: ggslns@gmail.com

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • Eugonia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women undergoing IVF treatment

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg donation
  • PGD cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing)
Procedure: intracytoplasmic sperm injection (ICSI)
All eggs will be fertilized by ICSI
Group II
Group II= egg retrieved in the 1st-2nd flush
Procedure: intracytoplasmic sperm injection (ICSI)
All eggs will be fertilized by ICSI
Group III
Group III= egg retrieved in the 3rd-5th flush
Procedure: intracytoplasmic sperm injection (ICSI)
All eggs will be fertilized by ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: Day 1 post oocyte retrieval
Number of fertilized eggs per oocyte retrieved
Day 1 post oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maturation rate
Time Frame: Day of oocyte retrieval
Number of mature (MII) eggs per oocyte retrieved
Day of oocyte retrieval
Good quality embryos
Time Frame: Day 2 post oocyte retrieval
Number of good quality embryos on Day 2
Day 2 post oocyte retrieval
Blastocyst formation rate
Time Frame: Day 5 post oocyte retrieval
Number of blastocysts on Day 5 per fertilized egg
Day 5 post oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Investigators

  • Study Director: Tryfon G Lainas, Phd, Eugonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Anticipated)

January 31, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • number of flushes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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