Follicular Flushing Using Double Lumen Needle Versus Direct Aspiration in Low Prognosis Patients According to the POSEIDON Criteria

NCT07270081 | Completed

• 1 other identifier: MR47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled clinical trial designed to evaluate whether follicular flushing increases the number of cumulus-oocyte complexes (COCs) retrieved compared to single aspiration in patients with poor ovarian response belonging to Poseidon groups 3 and 4. A total of 40 patients with poor ovarian response belonging to Poseidon groups 3 and 4 will be included. In each patient, one ovary will be randomized to the study technique (follicular flushing), and the other ovary will be randomized to the control technique (single aspiration).

Conditions

Poor Response to Ovulation Induction; Poor Response to Ovulation Induction Poseidon Type IV; Low Ovarian Reserve

Keywords

Follicular flushing; Poseidon 3 and 4; Poor responder; low ovarian reserve

Outcome Measures

Primary Outcomes (1)

• number of cumulus-oocyte complexes

  number of cumulus-oocyte complexes (COCs) retrieved after each aspiration

  During the egg retrieval

Secondary Outcomes (4)

• Oocyte recovery rate

  day of the egg retrieval

• Fertilization rate

  1 day after the egg retrieval

• Empty follicle rate

  day of the egg retrieval

• Procedure time

  In seconds from needle insertion to its withdrawal for each ovary

Study Arms (2)

Single Aspiration Arm

ACTIVE COMPARATOR

Oocytes will be retrieved from one ovary using single follicular aspiration

Procedure: follicular aspiration

Follicular Flushing Arm

EXPERIMENTAL

Oocytes will be retrieved from the contralateral ovary using follicular flushing, with up to three flushes per follicle if no cumulus-oocyte complex is obtained initially

Procedure: follicular flushing

Interventions

follicular flushing PROCEDURE

Follicles will be aspirated using 17G needles of the same gauge in both groups. For follicular flushing, the same type of needle used for single aspiration (Cook) will be employed. To eliminate dead space, the needle will be prefilled with flushing medium before starting the procedure. Aspiration pressure will be maintained at 190 mmHg during oocyte retrieval. In the follicular flushing group, if no cumulus-oocyte complex (COC) is recovered during the initial aspiration, follicular flushing will be performed until a COC is obtained, up to a maximum of three times. After three flushes, if no COC is retrieved, the procedure will be completed by rinsing with flushing medium to minimize the possibility of oocyte retention within the needle.

Follicular Flushing Arm

follicular aspiration PROCEDURE

In the single aspiration group, after aspirating all follicles, the needle will be rinsed with flushing medium to prevent the possibility of oocyte retention within the needle.

Single Aspiration Arm

Eligibility Criteria

• Age: Up to 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pacientes con baja respuesta ovárica grupos POSEIDON 3 y 4 (\< 35 años y RFA \<5 y/o AMH \< 1.2 ng/ml o \> 35 años≥ 35 años y RFA \<5 o AMH \<1.2 ng/mL respectivamente)
• Pacientes menores o igual a 43 años.
• Índice de Masa Corporal (IMC) de 18-35 kg/m2
• Estimulación ovárica para ICSI
• Presencia y accesibilidad de ambos ovarios.
• Ausencia de patología ovárica
• Cuando se cumplan los criterios de desencadenamiento para la maduración final del ovocito, cada ovario debe contener al menos un folículo mayor o igual a 14 mm.
• Haber dado su consentimiento por escrito.

You may not qualify if:

• Presence of a single ovary.
• Presence of ovarian pathology.
• Use of conventional IVF as the fertilization method.

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, Alicante, 03016, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Each participant will serve as her own control. One ovary will be randomized to single aspiration and the contralateral ovary to follicular flushing.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

ES (1)