Effect of Follicle Flushing on Oocyte Fertilization Rate

Infertility Clinical Trial

Official title:

Effect of Follicle Flushing on Oocyte Fertilization Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353285
• Other study ID #: number of flushes
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2017
• Last updated: January 17, 2018
• Start date: November 27, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: January 2018
• Source: Eugonia
• Contact: Tryfon G Lainas, PhD
• Phone: 00302107236333
• Email: tlainas[@]eugonia.com.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2018
• Est. primary completion date: January 31, 2018
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Infertility

Intervention

Procedure:
• intracytoplasmic sperm injection (ICSI)
All eggs will be fertilized by ICSI

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Number of fertilized eggs per oocyte retrieved	Day 1 post oocyte retrieval
Secondary	Maturation rate	Number of mature (MII) eggs per oocyte retrieved	Day of oocyte retrieval
Secondary	Good quality embryos	Number of good quality embryos on Day 2	Day 2 post oocyte retrieval
Secondary	Blastocyst formation rate	Number of blastocysts on Day 5 per fertilized egg	Day 5 post oocyte retrieval