Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial

CompletadoClinicalTrials.gov

ID: NCT03121924Tipo: INTERVENTIONALInicio: 1 de dic de 2015Fin estimado: 1 de ago de 2019

Traducción no disponible, mostrando original

Resumen

Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.

Descripción detallada

There is an intense communication inside the follicular structure. Bidirectional information between the oocyte and the granulosa cells is needed for a normal follicular development and oocyte competence. There are conflicting results on the effect of pre-incubation time in ICSI. It is not clear the proper time to denudate the oocyte from the somatic cells prior to ICSI, and some authors describe a negative impact of the premature cummulus removal on the ICSI results. The aim of this study is to investigate wheter a preincubation time between oocyte retireval and injection has any effect on the ICSI ( intracytoplasmatic sperm injection) results .

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 32 YearsSexo: FEMALE

Criterios de inclusión

Oocytes retrieved from healthy donors, younger than 32 years old , with proven maternity(preference), who meet the admission criteria of ovodonation program:
The oocytes included will be the product of antagonist stimulation protocol and with Gnrh agonists trigger. (see annex)
Healthy women under 50 years of age , who meet the criteria as receptors into the ovodonation program.
Oocytes retrieved after 36.5 h + -1 h of administration of triptorelin acetate.
Only mature oocytes, in stage MII, will be included and injected.
Use of fresh or thawed semen for the ICSI.

Criterios de exclusión

Cases of severe male factor such as azoospermia or severe oligo-astheno-teratospermia( alone or combinated)
Sperm samples from surgical procedures (biopsy / testicular or epididymal puncture)
Donors with a polycystic ovarian profile, according to The Androgen Excess and PCOS Society (AES), 2006.
Thawed donated oocytes
Oocytes from patients who have previously donated within a period of less than three months.
Donors whith poor response (oocyte retrieved less than \< 4 oocytes).
Suspicion or signs of Endometriosis in donor patient.

Intervenciones

procedure

timing for oocyte denudation and Intracytoplasmatic Sperm injection

Donated oocytes were randomly allocated to two groups concerning the time of cumulus corona removal. The first group: After oocyte retrieval, cumulus cells were immediately removed and then ICSI was performed; in the second group, the oocyte-cumulus complexes were incubated for 4 hours. Afterwards, the granulosa cells were removedand ICSI was immediately performed.

Ubicaciones

Hospital Italiano de Buenos Aires

Ciudad de Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalHospital Italiano de Buenos Aires

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