ClinicalTrials.gg
CompletedNCT05198401Updated Jan 20, 2022

The Impact of the Previous Exposure to Covid-19 Virus Infection on the Outcome of ICSI Cycles

An observational study in COVID-19 and IVF, sponsored by Al Baraka Fertility Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by Al Baraka Fertility Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
122
Ages
20 Years to 38 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • COVID-19
  • IVF

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 122 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Al Baraka Fertility Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All women underwent individualized antagonist protocol

Eligibility criteria

  • 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., (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
122 participants (actual)
Target follow-up
9 Months
Patient registry
Yes

Groups and cohorts

  • 1

    (previous covid-19 positive) n. =88

    Other: covid-19

  • 2

    (covid-19 negative) n.=91

Interventions

  • Othercovid-19

    viral infection

06

What researchers measure

Primary outcomes

  1. number of mature oocytes (MII)

    how many mature oocytes

    Time frame: 10 days

Secondary outcomes

  1. total number of blastocysts

    number of blastocysts

    Time frame: 15 days

  2. B-hcg

    the clinical pregnancy rate.

    Time frame: 4 weeks

07

Study locations

1 site
  • Kamal Eldin Abdalla Rageh
    Cairo, 15006, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2020 to primary completion in May 2021, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2022
First posted
Jan 20, 2022
StartActual
Aug 1, 2020
Primary completionActual
May 2, 2021
CompletionActual
May 2, 2021
Last update
Jan 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05198401
Lead sponsor
Al Baraka Fertility Hospital
Responsible party
Dr. Kamal Rageh (Doctor, Al Baraka Fertility Hospital) — Principal investigator
First posted
Jan 20, 2022
Start date
Aug 1, 2020
Primary completion
May 2, 2021
Completion
May 2, 2021
Last update
Jan 20, 2022
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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