Skip to main content
OpenTrials
Completed

NCT Number: NCT03121924

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Ciudad de Buenos Aires, Buenos Aires, C1199ABB, Argentina

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: cumulus corona removed, granulosa cells removed

Primary outcomes

  1. Number of M2 oocytes at injection

    Time frame: four hours after oocyte retrieval

    Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI

  2. Number of normal fertilized oocytes after ICSI

    Time frame: 24 hours

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

  3. Number of cleaving embryos

    Time frame: 72 hours

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

  4. Number of TOP embryos

    Time frame: 72 hours

    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.

Secondary outcomes

  1. Implantation rate

    Time frame: 14 days after embryo trasfer

    The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos.

  2. Clinical pregnancy rate

    Time frame: 6 to 7 week

    Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Apr 20, 2017
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.