Infertility, FemaleNCT04185623
Time Lag for Oocyte Denudation: A Better Choice for ICSI Outcome?!
An observational study of Infertility, Female, run by Ahmed Saad at 1 site in Egypt.
Trial summary
This study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development. Read more about this study
- Who is it for?
- Ages 24 to 37 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- denudation time lag
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Dec 2020
- 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 24 to 37 years
- Women only
- No healthy volunteers
- Adult
Study population: couples who came seeking fertility through our IVF center
Who may be able to join
- Women 24-37 years old
- With good ovarian reserve
- Induction using Long agonist protocol
- unexplained infertility
Who cannot join
- severe male factor
- Testicular samples for ICSI
- poor ovarian reserve
- no of oocytes collected less than 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Lag for Oocyte Denudation:Is it a Better Choice for ICSI Outcome?!
This study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development.
Read the detailed description
Patients under 37 year old who were treated with controlled ovarian stimulation for ICSI were randomly divided into 2 groups; Group A: Oocytes were denudated immediately after oocyte retrieval , Group B: Oocytes were denudated 2 hours after retrieval and both groups were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups.
- Conditions
- Infertility, Female
- Being tested
- denudation time lag
- Keywords
- denudation timing ICSI timing oocyte aging
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denudation time lagProcedure or surgery
The time between ovum pickup and denudation of oocyte
| Study group | Role | What they receive |
|---|---|---|
| Group A (immediate denudation) | Oocytes were denudated immediately after oocyte retrieval and were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups. Receives: Procedure: denudation time lag | |
| Group B ( 2hs denudation after ovum pickup) | Oocytes were denudated 2 hours after retrieval and were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups. Receives: Procedure: denudation time lag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 5, good quality blastocyst
Assessment were done according to gardener classification
Measured: 120 hour post ovum pickup
Secondary outcomes (1)
clinical pregnancy
Assessment was done by observation of a gestational sac at 6 wks
Measured: 6 weeks from the last normal menstrual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Saad
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Sponsor-investigator, Ahmed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185623
- Sponsor's protocol ID
- Hawaa-8
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Lag for Oocyte Denudation:Is it a Better Choice for ICSI Outcome?!
- ClinicalTrials.gov ID
- NCT04185623
- Acronym / sponsor ID
- Hawaa-8
- Conditions
- Infertility, Female
- Keywords
- denudation timing ICSI timing oocyte aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ahmed SaadUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 4 Dec 2019 (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.
This study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development.
Detailed description
Patients under 37 year old who were treated with controlled ovarian stimulation for ICSI were randomly divided into 2 groups; Group A: Oocytes were denudated immediately after oocyte retrieval , Group B: Oocytes were denudated 2 hours after retrieval and both groups were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (immediate denudation) | – | Procedure: denudation time lagOocytes were denudated immediately after oocyte retrieval and were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups. |
| Group B ( 2hs denudation after ovum pickup) | – | Procedure: denudation time lagOocytes were denudated 2 hours after retrieval and were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups. |
Who may qualify
- Ages
- 24 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- couples who came seeking fertility through our IVF center
Key inclusion criteria (4 listed)
- Women 24-37 years old
- With good ovarian reserve
- Induction using Long agonist protocol
- unexplained infertility
Key exclusion criteria (4 listed)
- severe male factor
- Testicular samples for ICSI
- poor ovarian reserve
- no of oocytes collected less than 4
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 |
|---|---|---|
| denudation time lagThe time between ovum pickup and denudation of oocyte | Procedure or surgery | Group A (immediate denudation), Group B ( 2hs denudation after ovum pickup) |
Primary outcome
Day 5, good quality blastocyst
Time frame: 120 hour post ovum pickup
Assessment were done according to gardener classification
1 secondary outcome
clinical pregnancy
Time frame: 6 weeks from the last normal menstrual period
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 21 Sep 2022.
- Individual participant dataSharing planned: Yes. after completion of the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ahmed Saad at 1 site in Egypt.
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 4 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 21 Sep 2022. 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 Egypt. 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?
Day 5, good quality blastocyst (time frame: 120 hour post ovum pickup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022.