NCT05435430

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 26, 2022

Last Update Submit

June 26, 2022

Conditions

Infertility, Female

Keywords

SARS COV 19,IVF,OVARINA RESERVE,PREGNANCY

Outcome Measures

Primary Outcomes (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.

    18 months

Secondary Outcomes (1)

  • secondary outcomes

    18 months

Study Arms (1)

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

Interventions

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.

women with previously SARS-COV2 infection.

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aoor Villa Sofia Cervello

Palermo, 90100, Italy

RECRUITING

Related Publications (7)

  • 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.

    PMID: 23928476BACKGROUND

  • 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].

    BACKGROUND

  • 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.

    PMID: 33632754BACKGROUND

  • 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.

    PMID: 32466994BACKGROUND

  • 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.

    PMID: 34640536BACKGROUND

  • 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.

    PMID: 35309055BACKGROUND

  • 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.

    PMID: 26100348RESULT

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Giuseppe Gullo, MD.Ph.D

    AOOR VILLA SOFIA CERVELLO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Gullo, MD.Ph.D

CONTACT

+393336103998gullogiuseppe@libero.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GIUSEPPE GULLO MD. Ph.D

Study Record Dates

First Submitted

June 26, 2022

First Posted

June 28, 2022

Study Start

September 1, 2022

Primary Completion

September 30, 2023

Study Completion

March 1, 2024

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)