COVID-19 Infection and Reproductive Health in Infertile Women (COVINF)

June 26, 2022 updated by: GIUSEPPE GULLO, University of Palermo

Post-COVID-19 Infection and Reproductive Health in Women Undergoing I.V.F. Treatment

An increased number of women has been infected by COVID-19 in the last 2 years SARS-CoV-2 infection could have a role in potential disturbances on hormon levels and human fertility Has not completely demonstrated COVID-19 effects on female reproductive function and further research can be undertaken.

The proposed multicenter study will be simple and rapid, and attractive for the scientific community.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

COVID-19 virus is classified as a respiratory disease that drastically changed our daily life and perspective (1) can be mainly transmitted via respiratory droplets, however, there are recently published reports suggested its ability to transmit via sexual intercourse, assisted reproductive technology (ART) treatments, pregnancy, and nursing. ART specialists should be precautious, carefully following the situation while contributing by sharing novel evidence to counsel our patients (2).

However, there are no comprehensive reviews to explore the association between COVID-19 and female fertility comprehensively.Its of major importance to provide in-depth research explaining the underlying mechanism of SARS-CoV-2 infection and its impact on human reproductive organs and fertility (3).

Ovarian reserve is a key determinant of female fertility. In this study we observe the potential effects of SARS-CoV-2 infection on the principal indicators of ovarian reserve function as anti-Müllerian hormone (AMH); basal follicle-stimulating hormone (FSH), basal luteinising hormone (LH) basal oestradiol (E2) antral follicle count (AFC).

Questions regarding the potential risks of sexual transmission during intercourse and/or application of ART, vertical transmission (throughout pregnancy, delivery, and breastfeeding), the health of pregnant and postpartum women, and fetal or postnatal health problems of neonates/children remain largely unanswered (4,5).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Palermo, Italy, 90100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

mechanism of SARS-CoV-2 infection and its impact on human reproductive organs and fertility.

Ovarian reserve is a key determinant of female fertility. In this study we observe the potential effects of SARS-CoV-2 infection on the principal indicators of ovarian reserve function as anti-Müllerian hormone (AMH); basal follicle-stimulating hormone (FSH), basal luteinising hormone (LH) basal oestradiol (E2) antral follicle count (AFC).

Description

Inclusion Criteria:

Women 24-43 years of age Previous history of COVID-19 infection INFERTILITY DIAGNOSIS

Exclusion Criteria:

Women with current symptoms of COVID-19 infection Positive for HIV or the presence of active viral hepatitis Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
women with previously SARS-COV2 infection.

2 group from 2 IVF CENTER with egual criteria :

INCLUSION CRITERIA:

  • Women 24-43 years of age
  • Previous history of COVID-19 infection
  • INFERTILITY DIAGNOSIS

ESCLUSION CRITERIA:

  • women with current symptoms of COVID-19 infection
  • Positive for HIV or the presence of active viral hepatitis
  • Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments
Other: PERSPECTIVE, MULTICENTRIC and observational
we will enroll women with 25-45ys old and previously SARS-COV2 infection. first outcome to be investigate the impact of SARS-COV2 infection on female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research, in a path of medically procreation assisted programm and on any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection compared to the pre-infection period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main outcome
Time Frame: 18 months
To investigate how the SARS-COV2 infection affects the female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research in a path of medically assisted procreation and any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection.19 compared to the pre-infection period.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary outcomes
Time Frame: 18 months

Quantification of the number of good quality oocytes (MII) . Number of embryos on day 3 (Morula) or day 5 (blastocyst) of development transferred to the patients.

Thickness of the endometrium at the time of embryo transfer (ET).
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Giuseppe Gullo, MD.Ph.D, Aoor Villa Sofia Cervello

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

June 26, 2022

First Posted (Actual)

June 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOOR VILLA SOFIA CERVELLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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