Value of Follicular Flushing. Randomised Controlled Trial

NCT ID: NCT05473455

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2022-12-31

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).

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Follicular aspiration with addition of follicular flushing.

All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle)

Group Type: EXPERIMENTAL

Experimental: Follicular aspiration with addition of follicular flushing.

Intervention Type: PROCEDURE

Follicular flushing if necessary up to 5 times using a double lumen needle for oocyte recovery

Follicular aspiration only.

All follicles will be aspirated and no flushing will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental: Follicular aspiration with addition of follicular flushing.

Follicular flushing if necessary up to 5 times using a double lumen needle for oocyte recovery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eugonia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lainas, PhD

Role: STUDY_DIRECTOR

Eugonia

Locations

Eugonia Unit of Assisted Reproduction

Athens, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 28333185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28276189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23065177 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37632249 (View on PubMed)

Other Identifiers

Flushing RCT

Identifier Type: -

Identifier Source: org_study_id