Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2026-01-14
2029-01-20
Brief Summary
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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.
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Detailed Description
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Achieving pregnancy and live birth depends on several factors. The most important is the woman's age, as the advanced female reproductive age reduces the ovarian reserve and increases the chromosomal abnormalities of the remaining oocytes. The other important factor is the number of oocytes retrieved.
Follicular flushing aims to increase the number of mature oocytes retrieved at oocyte retrieval. The present thesis investigates the role of follicular flushing at oocyte retrieval.
The randomized study will be conducted in women undergoing ovarian stimulation with recombinant follicle-stimulating hormone (recFSH) and suppression of the premature rise of luteinizing hormone (LH) using a gonadotropin-releasing hormone (GnRH) antagonist or Progestin Primed Ovarian Stimulation (PPOS). Induction of final oocyte maturation will be done with recombinant human chorionic gonadotropin (rec hCG) or an agonist of GnRH.
Women with at least one follicle of a mean diameter of 11 millimetres or more in each ovary will be eligible to participate in the studies.
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.
The outcomes are the number of oocytes and mature oocytes retrieved during oocyte retrieval, 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.
This study requires 75 patients (25 per response category: poor, normal, high responders) to rigorously evaluate whether follicular flushing with single-lumen needles produces clinically meaningful improvements in oocyte yield. We employed multiple conservative assumptions to ensure adequate power even under pessimistic scenarios.
Sample size was calculated for a mixed-design ANOVA testing the Response × Technique interaction. Our published pilot study (Lainas et al., HR, 2023, N=105) using double-lumen needles demonstrated large effects, but we conservatively assume single-lumen needles will show only 50-70% of these effects. We further assumed: (1) within-ovary correlations of ρ=0.35 (lower than pilot's 0.44-0.59), (2) standard deviations 20% higher than pilot data, and (3) 90% power requirement (vs. standard 80%).
Under these ultra-conservative assumptions (50% of pilot effects), n=25 per group provides 82% power. For more realistic scenarios (70-80% of pilot effects), power exceeds 90-98%. This sample size accommodates 5% attrition (target enrollment N=79), which is appropriate for within-ovary designs where dropout is minimal. The conservative approach ensures the study can detect meaningful clinical differences while satisfying rigorous peer review standards and protecting against optimistic assumptions about equipment transition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Follicular flushing
Follicular flushing
follicular flushing
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.
Simple aspiration
Simple aspiration
Simple aspiration
Simple aspiration in IVF is the technique used during oocyte retrieval to retrieve the oocytes from the ovaries.
Interventions
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follicular flushing
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.
Simple aspiration
Simple aspiration in IVF is the technique used during oocyte retrieval to retrieve the oocytes from the ovaries.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* History of ovarian surgery
* Monofollicular growth
* Presence of only one ovary
* Ovary not accessible at oocyte retrieval
18 Years
46 Years
FEMALE
No
Sponsors
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Eugonia IVF Unit, Athens, Greece
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
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E.M. Kolibianakis
Professor in Obstetrics and Gynecology and Assisted Reproduction
Principal Investigators
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Efstratios Kolibianakis, Professor
Role: PRINCIPAL_INVESTIGATOR
Unit of Human Reproduction, Aristotle University of Thessaloniki
Locations
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Eugonia IVF
Athens, , Greece
Aristotle University of Thessaloniki
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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UHR-18
Identifier Type: -
Identifier Source: org_study_id
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