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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198401
• Other study ID #: covid/kamal
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: May 2, 2021

Study information

• Verified date: January 2022
• Source: Al Baraka Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2, 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19
• IVF
• Virus Diseases

Intervention

Other:
• covid-19
viral infection

Locations

Country	Name	City	State
Egypt	Kamal Eldin Abdalla Rageh	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al Baraka Fertility Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mature oocytes (MII)	how many mature oocytes	10 days
Secondary	total number of blastocysts	number of blastocysts	15 days
Secondary	B-hcg	the clinical pregnancy rate.	4 weeks