Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model
NCT ID: NCT03121924
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
375 participants
INTERVENTIONAL
2015-12-01
2019-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 .
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediately oocyte denudation
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 .
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.
Delayed oocyte denudation
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 .
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
32 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Romina I Pesce, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Italiano de Buenos Aires
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Harrison KL, Wilson LM, Breen TM, Pope AK, Cummins JM, Hennessey JF. Fertilization of human oocytes in relation to varying delay before insemination. Fertil Steril. 1988 Aug;50(2):294-7. doi: 10.1016/s0015-0282(16)60076-6.
Jacobs M, Stolwijk AM, Wetzels AM. The effect of insemination/injection time on the results of IVF and ICSI. Hum Reprod. 2001 Aug;16(8):1708-13. doi: 10.1093/humrep/16.8.1708.
Rienzi L, Ubaldi F, Anniballo R, Cerulo G, Greco E. Preincubation of human oocytes may improve fertilization and embryo quality after intracytoplasmic sperm injection. Hum Reprod. 1998 Apr;13(4):1014-9. doi: 10.1093/humrep/13.4.1014.
Van de Velde H, De Vos A, Joris H, Nagy ZP, Van Steirteghem AC. Effect of timing of oocyte denudation and micro-injection on survival, fertilization and embryo quality after intracytoplasmic sperm injection. Hum Reprod. 1998 Nov;13(11):3160-4. doi: 10.1093/humrep/13.11.3160.
Yanagida K, Yazawa H, Katayose H, Suzuki K, Hoshi K, Sato A. Influence of oocyte preincubation time on fertilization after intracytoplasmic sperm injection. Hum Reprod. 1998 Aug;13(8):2223-6. doi: 10.1093/humrep/13.8.2223.
Ho JY, Chen MJ, Yi YC, Guu HF, Ho ES. The effect of preincubation period of oocytes on nuclear maturity, fertilization rate, embryo quality, and pregnancy outcome in IVF and ICSI. J Assist Reprod Genet. 2003 Sep;20(9):358-64. doi: 10.1023/a:1025476910771.
Hassan HA. Cumulus cell contribution to cytoplasmic maturation and oocyte developmental competence in vitro. J Assist Reprod Genet. 2001 Oct;18(10):539-43. doi: 10.1023/a:1011901923261.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2500
Identifier Type: -
Identifier Source: org_study_id