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Infertility, FemaleCOVINFNCT05435430

COVID-19 Infection and Reproductive Health in Infertile Women

An observational study of Infertility, Female, run by University of Palermo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female
What is being tested?
PERSPECTIVE, MULTICENTRIC and observational
How many people
150 participants
Where
1 siteItaly
Study dates
1 Sep 2022to 1 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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).

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Giuseppe Gullo, MD.Ph.D contact

+393336103998

gullogiuseppe@libero.it

Italy1 site, 1 recruiting

  • Aoor Villa Sofia Cervello

    Palermo, 90100

    Giuseppe Gullo, MD, MD, gullogiuseppe@libero.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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).

Being tested
PERSPECTIVE, MULTICENTRIC and observational
Keywords
SARS COV 19,IVF,OVARINA RESERVE,PREGNANCY
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PERSPECTIVE, MULTICENTRIC and observationalOther

    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.

Study groups in NCT05435430
Study groupRoleWhat they receive
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
Receives: Other: PERSPECTIVE, MULTICENTRIC and observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Main outcome

    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.

    Measured: 18 months

Secondary outcomes (1)

  1. secondary outcomes

    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).

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435430
Sponsor's protocol ID
AOOR VILLA SOFIA CERVELLO
Acronym
COVINF
Status last verified
Jun 2022
First submitted
26 Jun 2022
Last updated
28 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reis S, Xavier MR, Coelho R, Montenegro N. Psychological impact of single and multiple courses of assisted reproductive treatments in couples: a comparative study. Eur J Obstet Gynecol Reprod Biol. 2013 Nov;171(1):61-6. doi: 10.1016/j.ejogrb.2013.07.034. Epub 2013 Aug 6.

    PubMed 23928476

  • 3. World Health Organization. Coronavirus disease 2019 (COVID-2019) situation Report-49, 2020. Available: https://www.who.int/ emergencies/diseases/novel-coronavirus-2019 [Accessed 2 Sep 2020].

  • Li F, Lu H, Zhang Q, Li X, Wang T, Liu Q, Yang Q, Qiang L. Impact of COVID-19 on female fertility: a systematic review and meta-analysis protocol. BMJ Open. 2021 Feb 25;11(2):e045524. doi: 10.1136/bmjopen-2020-045524.

    PubMed 33632754

  • Li R, Yin T, Fang F, Li Q, Chen J, Wang Y, Hao Y, Wu G, Duan P, Wang Y, Cheng D, Zhou Q, Zafar MI, Xiong C, Li H, Yang J, Qiao J. Potential risks of SARS-CoV-2 infection on reproductive health. Reprod Biomed Online. 2020 Jul;41(1):89-95. doi: 10.1016/j.rbmo.2020.04.018. Epub 2020 Apr 30.

    PubMed 32466994

  • Markiewicz-Gospodarek A, Wdowiak P, Czeczelewski M, Forma A, Flieger J, Januszewski J, Radzikowska-Buchner E, Baj J. The Impact of SARS-CoV-2 Infection on Fertility and Female and Male Reproductive Systems. J Clin Med. 2021 Sep 29;10(19):4520. doi: 10.3390/jcm10194520.

    PubMed 34640536

  • D'Ippolito S, Turchiano F, Vitagliano A, Scutiero G, Lanzone A, Scambia G, Greco P. Is There a Role for SARS-CoV-2/COVID-19 on the Female Reproductive System? Front Physiol. 2022 Mar 2;13:845156. doi: 10.3389/fphys.2022.845156. eCollection 2022.

    PubMed 35309055

  • Maroufizadeh S, Karimi E, Vesali S, Omani Samani R. Anxiety and depression after failure of assisted reproductive treatment among patients experiencing infertility. Int J Gynaecol Obstet. 2015 Sep;130(3):253-6. doi: 10.1016/j.ijgo.2015.03.044. Epub 2015 Jun 10.

    PubMed 26100348

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Female, run by University of Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Gullo, MD.Ph.D (+393336103998, gullogiuseppe@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Main outcome (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05435430, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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