Clinical trial NCT05473455: Value of Follicular Flushing. Randomised Controlled Trial
Official title: Does Addition of Follicular Flushing to the Initial Aspiration Lead to Higher Numbers of Oocytes Retrieved in Women Undergoing Oocyte Retrieval? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Follicular Flushing
Oocyte Retrieval
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: There is an ongoing debate regarding the effectiveness of follicular flushing during oocyte retrieval. Currently published studies and metanalyses suggest that follicular flushing does not improve live birth rate, clinical pregnancy rate or the number of oocytes retrieved. However, currently published studies may be confounded by the types of needle used, aspiration pressures, number of times flushing is repeated, etc. Additionally, follicular flushing should be examined in specific patient populations according to their response to ovarian stimulation.

In the current study, each woman will have one ovary (right or left) randomly assigned to be aspirated with or without the addition of follicular flushing. This study design ensures that clinical and demographic characteristics of the couple will not affect the outcomes evaluated. The primary endpoints will be the number of oocytes retrieved per ovary assigned to each group. Secondary outcomes will be the oocyte recovery rate (oocytes retrieved per follicle aspirated) oocyte maturation rate, fertilization rate, and embryo development per ovary assigned to each group.

The study population will include three subgroups according to observed ovarian response to ovarian stimulation (poor responders, normal responders, hyper responders). Assuming a minimum clinically significant difference in oocyte yield of 1 oocyte, a sample size of twenty patients per subgroup is required to yield 80% power.

Patients aged \<43 years with the presence of at least one follicles \>11mm in each ovary on the day of triggering final oocyte maturation will be eligible for inclusion in the study. 60 patients (20 in each of the aforementioned subgroup) will be recruited and just prior to oocyte retrieval their left and right ovaries will be randomly allocated into flushing or the no-flushing group. In both ovaries all follicles greater than 11mm will be punctured by the same 16G double lumen needle, using the same aspiration pressure. In the flushing group, flushing will be performed up to a maximum of five times or until a cumulus oocyte complex (COC) is retrieved.

In the control group all follicles greater than 11mm will be aspirated by the same double lumen needle and no flushing will be performed.

All COCs will be grouped according to the ovary they originated from by the embryologists and their development will be recorded until Day 3 following fertilization (Number of MII oocytes, number of fertilized oocytes, number good quality Day 3 embryos).

Eligibility criteria: Inclusion Criteria:

* Presence of both ovaries
* 18-43 years old
* At least one follicle \>11mm present in each ovary on day of triggering final oocyte maturation.

Exclusion Criteria:

* Ovarian surgery
* Monofolicular development

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: During oocyte collection (usually 10-30 minutes)
Secondary outcomes:
measure: Oocyte recovery rate
timeFrame: During oocyte collection (usually 10-30 minutes)
measure: Oocyte maturation rate
timeFrame: During oocyte denudation (usually 10-30 minutes)
measure: Fertilization rate
timeFrame: During fertilisation check (usually 10 minutes)
measure: Percentage of good quality embryos on day 2/3
timeFrame: During embryo evaluation (usually 10 minutes)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Unit of Assisted Reproduction
Study officials:
affiliation: Eugonia
name: Lainas, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.