RecruitingNot ApplicableNCT07270081

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


Sponsor

Instituto Bernabeu

Enrollment

40 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMax Age: 43 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria3

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

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Interventions

PROCEDUREfollicular flushing

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.

PROCEDUREfollicular aspiration

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.


Locations(1)

Instituto Bernabeu

Alicante, Alicante, Spain

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NCT07270081


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