About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of ovarian cyst of endometriosis
History of ovarian surgery
Monofollicular growth
Presence of only one ovary
Trial design
Parallel
Treatments tested in this trial
follicular flushing
Other interventionFollicular 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
Other interventionSimple aspiration in IVF is the technique used during oocyte retrieval to retrieve the oocytes from the ovaries.
Treatment groups
Trial outcomes
Primary outcomes
Number of oocytes retrieved
Oocytes retrieved at oocyte retrieval are collected in the laboratory
Secondary outcomes
Number of mature oocytes retrieved
Maturity of oocytes retrieved is observed in the laboratory about 2 hours after oocyte retrieval
Oocyte retrieval rate
Oocytes retrieved per mature follicles observed at the ultrasound on the day of trigger of oocyte maturation
Mature oocyte retrieval rate
Mature oocytes per number of mature follicles at the trigger of oocyte maturation
Rate of mature oocytes / total number of oocytes retrieved
Rate of mature oocytes per total number of oocytes retrieved
Sponsors and contacts
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Aristotle University Of Thessaloniki
Lead sponsor
Eugonia IVF Unit, Athens, Greece
Collaborator
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