Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, C1199ABB, Argentina
NCT Number: NCT03121924
Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.
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Notify Me18 year–32 year
Female
Interventional
Not applicable
Ciudad de Buenos Aires, Buenos Aires, C1199ABB, Argentina
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 .
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: cumulus corona removed, granulosa cells removed
Time frame: four hours after oocyte retrieval
Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI
Time frame: 24 hours
Asessment of the normal fertilization rate was made 24 hours after the intervention.
Time frame: 72 hours
The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.
Time frame: 72 hours
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.
Time frame: 14 days after embryo trasfer
The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos.
Time frame: 6 to 7 week
Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen.
Hospital Italiano de Buenos Aires
Other
Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial
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