The Role of Follicular Flushing at Oocyte Retrieval

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-46
SponsorAristotle University Of Thessaloniki

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • follicular flushing

    Other intervention

    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

    Other intervention

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Follicular flushingActive comparator 1 intervention
Group B: Simple aspirationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of oocytes retrieved

Oocytes retrieved at oocyte retrieval are collected in the laboratory

Time frame
Day 0

Secondary outcomes

1

Number of mature oocytes retrieved

Maturity of oocytes retrieved is observed in the laboratory about 2 hours after oocyte retrieval

Time frame
Day 0
2

Oocyte retrieval rate

Oocytes retrieved per mature follicles observed at the ultrasound on the day of trigger of oocyte maturation

Time frame
Day 0
3

Mature oocyte retrieval rate

Mature oocytes per number of mature follicles at the trigger of oocyte maturation

Time frame
Day 0
4

Rate of mature oocytes / total number of oocytes retrieved

Rate of mature oocytes per total number of oocytes retrieved

Time frame
Day 0

Other outcomes

Sponsors and contacts

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Aristotle University Of Thessaloniki

Lead sponsor

Eugonia IVF Unit, Athens, Greece

Collaborator

This trial is not recruiting at the moment. You can still explore other options: