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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IVF, COVID-19

Intervention / Treatment
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* Other: covid-19


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>(previous covid-19 positive) n. =88 | Other: covid-19<br>* viral infection<br>|
| 2<br>(covid-19 negative) n.=91 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mature oocytes (MII) | how many mature oocytes | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of blastocysts | number of blastocysts | 15 days | 
| B-hcg | the clinical pregnancy rate. | 4 weeks |