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

NCT ID: NCT05198401

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-05-02

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.

Conditions

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COVID-19 IVF

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

(previous covid-19 positive) n. =88

covid-19

Intervention Type OTHER

viral infection

2

(covid-19 negative) n.=91

No interventions assigned to this group

Interventions

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covid-19

viral infection

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

, 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Al Baraka Fertility Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kamal Rageh

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kamal Eldin Abdalla Rageh

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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covid/kamal

Identifier Type: -

Identifier Source: org_study_id

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