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

Fertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121924
• Other study ID #: 2500
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fertility

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