Value of Follicular Flushing. Randomised Controlled Trial

Infertility Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05473455
• Other study ID #: Flushing RCT
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Infertility

Intervention

Procedure:
• Experimental: Follicular aspiration with addition of follicular flushing.
Follicular flushing if necessary up to 5 times using a double lumen needle for oocyte recovery

Locations

Country	Name	City	State
Greece	Eugonia Unit of Assisted Reproduction	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	Number of oocytes retrieved per ovary randomised	During oocyte collection (usually 10-30 minutes)
Secondary	Oocyte recovery rate	Number of oocytes retrieved per follicle aspirated	During oocyte collection (usually 10-30 minutes)
Secondary	Oocyte maturation rate	Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised	During oocyte denudation (usually 10-30 minutes)
Secondary	Fertilization rate	Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised	During fertilisation check (usually 10 minutes)
Secondary	Percentage of good quality embryos on day 2/3	Number of good quality embryos divided by the number of fertilized oocytes per ovary randomised	During embryo evaluation (usually 10 minutes)