The Role of Follicular Flushing at Oocyte Retrieval

NCT07335016 | Not Yet Recruiting DMC

• 1 other identifier: UHR-18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

In vitro fertilization (IVF) is the most common method of medically assisted reproduction, involving fertilization of the egg by sperm in a lab. The process includes ovarian stimulation, oocyte retrieval, fertilization and culture, and embryo transfer. The success of IVF depends mainly on female age-as age increases, ovarian reserve and oocyte quality decrease-and the number of oocytes retrieved. This study investigates whether follicular flushing during oocyte retrieval can increase the number of mature oocytes retrieved. This randomized study will be conducted in women undergoing ovarian stimulation with recombinant Folicullar Stimulating Hormone (FSH) and Gonadotropin-Releasing Hormone (GnRH) antagonist or Progestin Primed Ovarian Stimulation (PPOS) to suppress premature Luteinizing hormone (LH) rise. Final oocyte maturation will be triggered with recombinant Human chorionic gonadotropin (hCG) or GnRH agonist. Eligible participants will have at least one follicle ≥11 mm in each ovary. On the day of oocyte retrieval, one ovary will be randomized to undergo follicular flushing using a single-lumen needle and the other simple aspiration, using the same needle. All fertilized oocytes from both ovaries will be cultured, seperately, to the blastocyst stage. Study outcomes are the number of oocytes and mature oocytes retrieved, the oocyte retrieval rate, the mature oocyte retrieval rate, the maturation rate, the number of fertilized oocytes, the fertilisation rate, the number of blastocytes and the blastulation rate. Sample size of 75 patients (25 per response category: poor, normal, high) provides 82-98% power to detect clinically meaningful interaction effects (Cohen's f=0.19-0.34) between response category and technique (follicular flushing vs. simple aspiration) under conservative assumptions of 50-70% of pilot study effects, lower correlations (ρ=0.35), and increased variability (α=0.05, two-sided, 5% attrition buffer.

Conditions

Infertility (IVF Patients); Oocyte Retrieval for IVF

Keywords

ivf; follicular flushing; oocyte retrieval

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  Oocytes retrieved at oocyte retrieval are collected in the laboratory

  Day 0

Secondary Outcomes (8)

• Number of mature oocytes retrieved

  Day 0

• Oocyte retrieval rate

  Day 0

• Mature oocyte retrieval rate

  Day 0

• Rate of mature oocytes / total number of oocytes retrieved

  Day 0

• Number of fertilized oocytes

  Day 1

Study Arms (2)

Follicular flushing

ACTIVE COMPARATOR

Follicular flushing

Other: follicular flushing

Simple aspiration

ACTIVE COMPARATOR

Simple aspiration

Other: Simple aspiration

Interventions

Simple aspiration OTHER

Simple aspiration in IVF is the technique used during oocyte retrieval to retrieve the oocytes from the ovaries.

Simple aspiration

follicular flushing OTHER

Follicular flushing in IVF is a technique used during oocyte retrieval with the aim to increase the number of oocytes retrieved. In follicular flushing, after the initial aspiration, the follicle is rinsed (flushed) with a sterile fluid using the same needle. In the first arm, follicular flushing will be performed in the left ovary.

Follicular flushing

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ovarian stimulation with recFSH and GnRH antagonist or PPOS protocol
• Triggering final oocyte maturation with hCG or GnRH agonist
• The day of oocyte retrieval at least one follicle of mean diameter of 11mm in each ovary
• ICSI method of fertilisation.

You may not qualify if:

• Presence of ovarian cyst of endometriosis
• History of ovarian surgery
• Monofollicular growth
• Presence of only one ovary
• Ovary not accessible at oocyte retrieval

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Eugonia IVF Unit, Athens, Greece: collaborator

Study Sites (2)

Eugonia IVF

Athens, Greece

Location

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Infertility; Long Qt Syndrome 3

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Efstratios Kolibianakis, Professor

  Unit of Human Reproduction, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Efstratios Prof. Kolibianakis

CONTACT

+306937096078; stratis.kolibianakis@gmail.com

Theoni Tarlatzi

CONTACT

+306945853581; nonika.tarlatzi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Obstetrics and Gynecology and Assisted Reproduction

Model Details: This study design, where each patient undergoing IVF has one ovary randomized to follicular flushing and the contralateral ovary to simple aspiration, is classified as a parallel intervention study model with within-participant (or split-body) randomization at the organ level.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 12, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 20, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

GR (2)