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Effect of Follicle Flushing on Oocyte Fertilization Rate

NCT03353285 — Unknown, 60 participants, Eugonia
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RegistryNCT03353285
StatusUnknown
Study typeObservational
Enrollment60 (Estimated)
SponsorEugonia (Other)
ConditionsInfertility
Interventionsintracytoplasmic sperm injection (ICSI) (Procedure)
Datesstart 2017-11-27, primary completion 2018-01-31 (estimated), completion 2018-06-01 (estimated), first posted 2017-11-27, last updated 2018-01-18
Locations1 site in Greece

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-Summary

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

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • Fertilization rate [Day 1 post oocyte retrieval]: Number of fertilized eggs per oocyte retrieved

Secondary outcomes

  • 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

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

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

+Locations (1)

FacilityCityCountryStatus
EugoniaAthensGreeceRecruiting

+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. PMID 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. PMID 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. PMID 23065177

+Investigators

My Notes