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

Study Overview
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Brief Summary
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Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.

Detailed Description
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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 .

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

Conditions
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Fertility

Intervention / Treatment
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* Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediately oocyte denudation<br>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 . | Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection<br>* 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.<br>* Other names: granulosa cells removed;|
| Experimental: Delayed oocyte denudation<br>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 . | Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection<br>* 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.<br>* Other names: granulosa cells removed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of M2 oocytes at injection | Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI | four hours after oocyte retrieval | 
| Number of normal fertilized oocytes after ICSI | Asessment of the normal fertilization rate was made 24 hours after the intervention. | 24 hours | 
| Number of cleaving embryos | The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed. | 72 hours | 
| Number of TOP embryos | The embryos were morfologically classified into 4 categories . It considered TOP embryos those correctly fertilized at day 1, and with regular 6 to 8 cells at day 2 with less than 20% fragmentation and without multinuclear blastomeres. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos. | 14 days after embryo trasfer | 
| Clinical pregnancy rate | Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen. | 6 to 7 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte denudation, preincubation, icsi, oocyte donation