FertilityNCT03121924
Effect of Timing of Oocyte Denudation Before ICSI in an Oocyte Donation Model
A study testing timing for oocyte denudation and Intracytoplasmatic Sperm injection in people with Fertility, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model. Read more about this study
- Who is it for?
- Ages 18 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- timing for oocyte denudation and Intracytoplasmatic Sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2015to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, C1199ABB
About this study
Official title: Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial
Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.
Read the 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 .
- Conditions
- Fertility
- Being tested
- timing for oocyte denudation and Intracytoplasmatic Sperm injection
- Keywords
- oocyte denudation, preincubation, icsi, oocyte donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timing for oocyte denudation and Intracytoplasmatic Sperm injectionProcedure or surgery
Also called cumulus corona removed, granulosa cells removed
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of M2 oocytes at injection
Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI
Measured: 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.
Measured: 24 hours
Number of cleaving embryos
The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.
Measured: 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.
Measured: 72 hours
Secondary outcomes (2)
Implantation rate
The implantation rate was the ratio between the number of gestacional sacs and the number of transferred embryos.
Measured: 14 days after embryo trasfer
Clinical pregnancy rate
Clinical pregnancy is confirmed by ultrasonography ,when one or more gestational sacs with heart activity are seen.
Measured: 6 to 7 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 Dec 2015
- Primary completion1 Dec 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romina I Pesce, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121924
- Sponsor's protocol ID
- 2500
- Status last verified
- Aug 2019
- First submitted
- 27 Sep 2016
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 3294045Jacobs 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.
PubMed 11473969Rienzi 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.
PubMed 9619563Van 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.
PubMed 9853875Yanagida 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.
PubMed 9756300Ho 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.
PubMed 14531646Hassan 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.
PubMed 11699125
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03121924
- Acronym / sponsor ID
- 2500
- Conditions
- Fertility
- Keywords
- oocyte denudation, preincubation, icsi, oocyte donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Dec 2015
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediately oocyte denudation | Experimental | Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injectionAfter 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 . |
| Delayed oocyte denudation | Experimental | Procedure: timing for oocyte denudation and Intracytoplasmatic Sperm injectionAfter 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 . |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| timing for oocyte denudation and Intracytoplasmatic Sperm injectionAlso: cumulus corona removed, granulosa cells removedDonated 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. | Procedure or surgery | Delayed oocyte denudation, Immediately oocyte denudation |
Primary outcome
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
Number of normal fertilized oocytes after ICSI
Time frame: 24 hours
Asessment of the normal fertilization rate was made 24 hours after the intervention.
Number of cleaving embryos
Time frame: 72 hours
The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.
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.
2 secondary outcomes
Implantation rate
Time frame: 14 days after embryo trasfer
Clinical pregnancy rate
Time frame: 6 to 7 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Background: PubMed 3294045Harrison 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.
- Background: PubMed 11473969Jacobs 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.
- Results publication: PubMed 9619563Rienzi 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.
- Results publication: PubMed 9853875Van 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.
- Results publication: PubMed 9756300Yanagida 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.
- Results publication: PubMed 14531646Ho 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.
- Results publication: PubMed 11699125Hassan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romina I Pesce, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing timing for oocyte denudation and Intracytoplasmatic Sperm injection in people with Fertility, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of M2 oocytes at injection (time frame: four hours after oocyte retrieval). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03121924, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.