COVID-19NCT05198401
The Impact of the Previous Exposure to Covid-19 Virus Infection on the Outcome of ICSI Cycles
An observational study of COVID-19 and IVF, run by Al Baraka Fertility Hospital at 1 site in Egypt.
Trial summary
Whilst the global COVID-19 pandemic is still evolving and there are many unknowns about the long-term effects of the virus on fertility and pregnancy, we found ourselves in need to offer some evidence-based guidance, that's why we decided to go for this study, to evaluate the relation of the covid-19 and the outcome… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- What is being tested?
- covid-19
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 2 May 2021
- How long will I take part?
- 9 Months
- 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 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All women underwent individualized antagonist protocol
- Inclusion criteria were women who got recovered from Covid-19 based upon their history with positive test results confirmed via BeAware Bahrain phone application and Tawakkalna Saudi phone application; with age below 38 yrs., body mass index (BMI) below 30 kg/m2, who underwent antagonist protocol for IVF
- Exclusion criteria were chromosomal and genetic disorders, age> 38 years, BMI > 30, abnormal ultrasonogram of the uterine cavity (acquired or congenital), those who underwent long agonist protocol, and those cases with severe male factor, and abnormal embryos not suitable for transfer, we excluded also patients with those who got vaccinated against Covid-19 and those with current infection.
Trial locations and contacts
1 site in 1 country.
About this study
Whilst the global COVID-19 pandemic is still evolving and there are many unknowns about the long-term effects of the virus on fertility and pregnancy, we found ourselves in need to offer some evidence-based guidance, that's why we decided to go for this study, to evaluate the relation of the covid-19 and the outcome of IVF/ICSI cycles. we found that there is no clear evidence that the previous exposure to Covid-19 virus infection can affect the outcome of ICSI cycles significantly.
Read the detailed description
This is an observational study, for 122 ICSI cycles conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, and Al-Manea hospital, KSA between August 2020 and May 2021, and it was approved by the ethical committees. We compared the outcome results of those patients who got recovered from previous exposure to covid-19 (study group) with results of non-infected comparable patients (control group) After comparison of the basal characteristics in both groups, and we got assured that there is no significant difference regarding the demographic criteria between both groups, we found that there is no significant difference regarding the duration of stimulation, the total dose of stimulation, number of oocytes retrieved, number of metaphase 2 oocytes (MII), number of grade1-2 embryos, number of transferred embryos, day of embryo transfer and fertilization rate.
Although the fertilization rate was higher in Covid-19 free patients (52% vs. 50.6%), however, this difference is not statistically significant.
In the same way, the pregnancy rate was also higher in the covid-19 negative group (45.1% vs. 36.4%); however this difference was not statistically significant.
- Being tested
- covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid-19Other
viral infection
| Study group | Role | What they receive |
|---|---|---|
| 1 | (previous covid-19 positive) n. =88 Receives: Other: covid-19 | |
| 2 | (covid-19 negative) n.=91 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mature oocytes (MII)
how many mature oocytes
Measured: 10 days
Secondary outcomes (2)
total number of blastocysts
number of blastocysts
Measured: 15 days
B-hcg
the clinical pregnancy rate.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Aug 2020
- Primary completion2 May 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cross-sectional
- Enrolment
- 122 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamal Rageh, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198401
- Sponsor's protocol ID
- covid/kamal
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Previous Exposure to Covid-19 Virus Infection on the Outcome of ICSI Cycles
- ClinicalTrials.gov ID
- NCT05198401
- Acronym / sponsor ID
- covid/kamal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 20 Jan 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.
Whilst the global COVID-19 pandemic is still evolving and there are many unknowns about the long-term effects of the virus on fertility and pregnancy, we found ourselves in need to offer some evidence-based guidance, that's why we decided to go for this study, to evaluate the relation of the covid-19 and the outcome of IVF/ICSI cycles. we found that there is no clear evidence that the previous exposure to Covid-19 virus infection can affect the outcome of ICSI cycles significantly.
Detailed description
This is an observational study, for 122 ICSI cycles conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, and Al-Manea hospital, KSA between August 2020 and May 2021, and it was approved by the ethical committees. We compared the outcome results of those patients who got recovered from previous exposure to covid-19 (study group) with results of non-infected comparable patients (control group) After comparison of the basal characteristics in both groups, and we got assured that there is no significant difference regarding the demographic criteria between both groups, we found that there is no significant difference regarding the duration of stimulation, the total dose of stimulation, number of oocytes retrieved, number of metaphase 2 oocytes (MII), number of grade1-2 embryos, number of transferred embryos, day of embryo transfer and fertilization rate.
Although the fertilization rate was higher in Covid-19 free patients (52% vs. 50.6%), however, this difference is not statistically significant.
In the same way, the pregnancy rate was also higher in the covid-19 negative group (45.1% vs. 36.4%); however this difference was not statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: covid-19(previous covid-19 positive) n. =88 |
| 2 | – | –(covid-19 negative) n.=91 |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women underwent individualized antagonist protocol
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 |
|---|---|---|
| covid-19viral infection | Other | 1 |
Primary outcome
number of mature oocytes (MII)
Time frame: 10 days
how many mature oocytes
2 secondary outcomes
total number of blastocysts
Time frame: 15 days
B-hcg
Time frame: 4 weeks
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 20 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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 COVID-19 and IVF, run by Al Baraka Fertility Hospital 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?
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 20 Jan 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?
number of mature oocytes (MII) (time frame: 10 days). 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 20 Jan 2022.