Clinical trial NCT05435430: COVID-19 Infection and Reproductive Health in Infertile Women
Official title: Post-COVID-19 Infection and Reproductive Health in Women Undergoing I.V.F. Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: SARS COV 19,IVF,OVARINA RESERVE,PREGNANCY
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Main outcome
timeFrame: 18 months
Secondary outcomes:
measure: secondary outcomes
timeFrame: 18 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Aoor Villa Sofia Cervello
Study officials:
affiliation: AOOR VILLA SOFIA CERVELLO
name: Giuseppe Gullo, MD.Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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].
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.