Fertility
Conditions
Keywords
oocyte denudation, preincubation, icsi, oocyte donation
Brief summary
Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.
Detailed 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 .
Interventions
PROCEDUREtiming 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.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 32 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of M2 oocytes at injection | four hours after oocyte retrieval | Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI |
| Number of normal fertilized oocytes after ICSI | 24 hours | Asessment of the normal fertilization rate was made 24 hours after the intervention. |
| Number of cleaving embryos | 72 hours | The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed. |
| Number of TOP embryos | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 14 days after embryo trasfer | The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos. |
| Clinical pregnancy rate | 6 to 7 week | Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen. |
Countries
Argentina
Outcome results
None listed