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

NCT03121924 | Completed DMC

• 1 other identifier: 2500
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fertility

Keywords

oocyte denudation; preincubation; icsi; oocyte donation

Outcome Measures

Primary Outcomes (4)

• 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

• Number of normal fertilized oocytes after ICSI

  Asessment of the normal fertilization rate was made 24 hours after the intervention.

  24 hours

• Number of cleaving embryos

  The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.

  72 hours

• 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 Outcomes (2)

• Implantation rate

  14 days after embryo trasfer

• Clinical pregnancy rate

  6 to 7 week

Study Arms (2)

Immediately oocyte denudation

EXPERIMENTAL

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 .

Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection

Delayed oocyte denudation

EXPERIMENTAL

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 .

Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection

Interventions

timing for oocyte denudation and Intracytoplasmatic Sperm injection PROCEDURE

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.

Also known as: cumulus corona removed, granulosa cells removed

Delayed oocyte denudation; Immediately oocyte denudation

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad de Buenos Aires, Buenos Aires, C1199ABB, Argentina

Location

Related 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. doi: 10.1016/s0015-0282(16)60076-6.

  PMID: 3294045 BACKGROUND

• 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.

  PMID: 11473969 BACKGROUND

• 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.

  PMID: 9619563 RESULT

• 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.

  PMID: 9853875 RESULT

• 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.

  PMID: 9756300 RESULT

• 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.

  PMID: 14531646 RESULT

• 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.

  PMID: 11699125 RESULT

Study Officials

• Romina I Pesce, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: April 20, 2017
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: December 1, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)