Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: Fertility

Treatments: Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03121924

2500

Details and patient eligibility

About

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

Full description

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 .

Enrollment: 375 patients

Sex: Female

Ages: 18 to 32 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 2 patient groups

Immediately oocyte denudation

Experimental group

Description:

After the retrieval , sybling oocytes were assigned to one o more recipient and then ,the oocytes were randomized in two arms . The first arm is the immediately denudation and immediately ICSI of the oocytes, and in the second arm the oocyte are denuded and injected after 4 hours from the pick up .

Treatment:

Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection

Delayed oocyte denudation

Experimental group

Description:

After the retrieval , sybling oocytes were assigned to one o more recipient and then ,the oocytes were randomized in two arms . In this arm, the oocyte are denuded and injected after 4 hours from the pick up .

Treatment:

Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection