Effect of Follicle Flushing on Oocyte Fertilization Rate

• Conditions: Infertility
• Interventions: Procedure: intracytoplasmic sperm injection (ICSI)

• Registration Number: NCT03353285
• Lead Sponsor: Eugonia

Brief Summary

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

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study Start: 2017-11-27
• Study First Posted: 2017-11-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18
• Primary Completion: 2018-01-31
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fertilization rate	Day 1 post oocyte retrieval	Number of fertilized eggs per oocyte retrieved

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eugonia; 🇬🇷 Athens, Greece