Clinical trial NCT03121924: Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model
Official title: Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility
Keywords: oocyte denudation
preincubation
icsi
oocyte donation
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Number of M2 oocytes at injection
timeFrame: four hours after oocyte retrieval
measure: Number of normal fertilized oocytes after ICSI
timeFrame: 24 hours
measure: Number of cleaving embryos
timeFrame: 72 hours
measure: Number of TOP embryos
timeFrame: 72 hours
Secondary outcomes:
measure: Implantation rate
timeFrame: 14 days after embryo trasfer
measure: Clinical pregnancy rate
timeFrame: 6 to 7 week
Other outcomes:
Locations:
city: Ciudad de buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Romina I Pesce, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1093/humrep/16.8.1708.
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. doi: 10.1093/humrep/13.4.1014.
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. doi: 10.1093/humrep/13.11.3160.
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. doi: 10.1093/humrep/13.8.2223.
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. doi: 10.1023/a:1025476910771.
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. doi: 10.1023/a:1011901923261.