Value of Follicular Flushing. Randomised Controlled Trial

NCT05473455 | Completed

• 1 other identifier: Flushing RCT
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the addition of follicular flushing to the initial aspiration during oocyte retrieval increases the number of oocytes retrieved in women undergoing ovarian stimulation.

Conditions

Infertility

Keywords

Follicular Flushing; Oocyte Retrieval

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  Number of oocytes retrieved per ovary randomised

  During oocyte collection (usually 10-30 minutes)

Secondary Outcomes (4)

• Oocyte recovery rate

  During oocyte collection (usually 10-30 minutes)

• Oocyte maturation rate

  During oocyte denudation (usually 10-30 minutes)

• Fertilization rate

  During fertilisation check (usually 10 minutes)

• Percentage of good quality embryos on day 2/3

  During embryo evaluation (usually 10 minutes)

Study Arms (2)

Follicular aspiration with addition of follicular flushing.

EXPERIMENTAL

All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle)

Procedure: Experimental: Follicular aspiration with addition of follicular flushing.

Follicular aspiration only.

NO INTERVENTION

All follicles will be aspirated and no flushing will be applied.

Interventions

Experimental: Follicular aspiration with addition of follicular flushing. PROCEDURE

Follicular flushing if necessary up to 5 times using a double lumen needle for oocyte recovery

Follicular aspiration with addition of follicular flushing.

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Participants must have both ovaries present
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of both ovaries
• years old
• At least one follicle \>11mm present in each ovary on day of triggering final oocyte maturation.

You may not qualify if:

• Ovarian surgery
• Monofolicular development

Sponsors & Collaborators

• Eugonia: lead

Study Sites (1)

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lainas GT, Lainas TG, Makris AA, Xenariou MV, Petsas GK, Kolibianakis EM. Follicular flushing increases the number of oocytes retrieved: a randomized controlled trial. Hum Reprod. 2023 Oct 3;38(10):1927-1937. doi: 10.1093/humrep/dead169.

  PMID: 37632249 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lainas, PhD

  Eugonia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 26, 2022
• Study Start: July 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)