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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03121924
Other study ID # 2500
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2015
Est. completion date August 1, 2019

Study information

Verified date August 2019
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date August 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 32 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires Ciudad de buenos Aires Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (7)

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. — View Citation

Hassan HA. Cumulus cell contribution to cytoplasmic maturation and oocyte developmental competence in vitro. J Assist Reprod Genet. 2001 Oct;18(10):539-43. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Number of normal fertilized oocytes after ICSI Asessment of the normal fertilization rate was made 24 hours after the intervention. 24 hours
Primary Number of cleaving embryos The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed. 72 hours
Primary 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 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
Secondary Clinical pregnancy rate Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen. 6 to 7 week
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