Comparison of 2 Different Flow Rates During Oocyte Retrieval

NCT06019494 | Completed

• 1 other identifier: Flow rate for oocyte retrieval
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of different flow rates during oocyte retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.

Conditions

Infertility

Keywords

Flow rate; Aspiration pressure; Oocyte retrieval

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  Number of oocytes retrieved per ovary randomised.

  During oocyte retrieval

Secondary Outcomes (5)

• Oocyte recovery rate

  During oocyte retrieval

• Oocyte maturation rate

  2-3 hours post oocyte retrieval

• Average oocyte score

  2-3 hours post oocyte retrieval

• Fertilization rate

  Day 1 post oocyte retrieval

• Percentage of good quality blastocysts on day 5

  5 days post oocyte retrieval

Study Arms (2)

Low aspiration flow rate

EXPERIMENTAL

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.

Procedure: Oocyte retrieval with low aspiration flow rate

High aspiration flow rate

EXPERIMENTAL

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.

Procedure: Oocyte retrieval with high aspiration flow rate

Interventions

Oocyte retrieval with low aspiration flow rate PROCEDURE

All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.42 ml/sec.

Low aspiration flow rate

Oocyte retrieval with high aspiration flow rate PROCEDURE

High aspiration flow rate All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.62 ml/sec.

High aspiration flow rate

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Participants must have both ovaries present
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of both ovaries
• years old
• At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval

You may not qualify if:

• One or no ovaries present
• Monofollicular development
• Poor responders
• Previous history of hemorrhage during oocyte retrieval

Sponsors & Collaborators

• Eugonia: lead
• Aristotle University Of Thessaloniki: collaborator

Study Sites (1)

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

Location

Related Publications (1)

• Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.

  PMID: 26630267 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• George T Lainas, PhD

  Eugonia ART Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)