Fertility DisordersNCT05448859
Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality
An observational study of Fertility Disorders, run by Universitas Padjadjaran.
Trial summary
An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Read more about this study
- Who is it for?
- Ages 3 to 8 hours
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Observational
- 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 3 to 8 hours
- All sexes
- No healthy volunteers
- Child
Study population: Oocytes are derived from patients enrolled in IVF
Who may be able to join
- oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection
Who cannot join
- oocytes from patients >40 years old
- oocytes from primary infertility >5 years
- endometriosis
- polycystic ovarian syndrome
About this study
Official title: The Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality at Assisted Reproductive Technology Clinic
An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.
Read the detailed description
This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.
- Conditions
- Fertility Disorders
- Being tested
- intracytoplasmic sperm injection
- Keywords
- infertility, assisted reproductive technology, embryo quality, oocyte denudation, intracytoplasmic sperm injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracytoplasmic sperm injectionProcedure or surgery
Also called ICSI
injection of sperm into an oocyte in assisted reproductive technology
| Study group | Role | What they receive |
|---|---|---|
| 3-4 hours denudation | oocytes with 3-4 hours denudation time Receives: Procedure: intracytoplasmic sperm injection | |
| 4-5 hours denudation | oocytes with 4-5 hours denudation time Receives: Procedure: intracytoplasmic sperm injection | |
| 5-6 hours denudation time | oocytes with 5-6 hours denudation time Receives: Procedure: intracytoplasmic sperm injection | |
| 6-7 hours denudation time | oocytes with 6-7 hours denudation time Receives: Procedure: intracytoplasmic sperm injection | |
| more than 7 hours denudation time | oocytes with more than 7 hours denudation time Receives: Procedure: intracytoplasmic sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte denudation time
time measured for oocyte denudation
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dian Tjahyadi, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448859
- Sponsor's protocol ID
- OBGY-202206.02
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data on oocytes and IVF procedures are only available upon reasonable written request to the authors team.
Publications
Isiklar A, Mercan R, Balaban B, Alatas C, Aksoy S, Urman B. Impact of oocyte pre-incubation time on fertilization, embryo quality and pregnancy rate after intracytoplasmic sperm injection. Reprod Biomed Online. 2004 Jun;8(6):682-6. doi: 10.1016/s1472-6483(10)61649-5.
PubMed 15169586
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality at Assisted Reproductive Technology Clinic
- ClinicalTrials.gov ID
- NCT05448859
- Acronym / sponsor ID
- OBGY-202206.02
- Conditions
- Fertility Disorders
- Keywords
- infertility, assisted reproductive technology, embryo quality, oocyte denudation, intracytoplasmic sperm injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Jul 2022 (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.
An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.
Detailed description
This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 3-4 hours denudation | – | Procedure: intracytoplasmic sperm injectionoocytes with 3-4 hours denudation time |
| 4-5 hours denudation | – | Procedure: intracytoplasmic sperm injectionoocytes with 4-5 hours denudation time |
| 5-6 hours denudation time | – | Procedure: intracytoplasmic sperm injectionoocytes with 5-6 hours denudation time |
| 6-7 hours denudation time | – | Procedure: intracytoplasmic sperm injectionoocytes with 6-7 hours denudation time |
| more than 7 hours denudation time | – | Procedure: intracytoplasmic sperm injectionoocytes with more than 7 hours denudation time |
Who may qualify
- Ages
- 3 to 8 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Oocytes are derived from patients enrolled in IVF
Key inclusion criteria (1 listed)
- oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection
Key exclusion criteria (4 listed)
- oocytes from patients >40 years old
- oocytes from primary infertility >5 years
- endometriosis
- polycystic ovarian syndrome
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 |
|---|---|---|
| intracytoplasmic sperm injectionAlso: ICSIinjection of sperm into an oocyte in assisted reproductive technology | Procedure or surgery | 3-4 hours denudation, 4-5 hours denudation, 5-6 hours denudation time, 6-7 hours denudation time, more than 7 hours denudation time |
Primary outcome
Oocyte denudation time
Time frame: 3 hours
time measured for oocyte denudation
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 8 Jul 2022.
- Results publication: PubMed 15169586Isiklar A, Mercan R, Balaban B, Alatas C, Aksoy S, Urman B. Impact of oocyte pre-incubation time on fertilization, embryo quality and pregnancy rate after intracytoplasmic sperm injection. Reprod Biomed Online. 2004 Jun;8(6):682-6. doi: 10.1016/s1472-6483(10)61649-5.
- Individual participant dataSharing planned: Undecided. Anonymised data on oocytes and IVF procedures are only available upon reasonable written request to the authors team.
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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.
Dian Tjahyadi principal investigator
Universitas Padjadjaran
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders, run by Universitas Padjadjaran.
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 1 inclusion and 4 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Oocyte denudation time (time frame: 3 hours). 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 NCT05448859, which also lists 1 linked publication.
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 8 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.