Female Genital SchistosomiasisMATCHINGNCT07484256
MATCHING - feMAle geniTal sCHistosomiasis IN miGrants Female Genital Schistosomiasis in Migrants Presenting to an Outpatient Clinic in Italy: Prevalence and Clinical Impact
A study testing Cervical-vaginal swab in people with Female Genital Schistosomiasis, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the prevalence of female genital schistosomiasis (FGS) in the migrant population with gynecological problems who access our center's dedicated outpatient clinic. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Female Genital Schistosomiasis
- What is being tested?
- Cervical-vaginal swab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2025to Aug 2027
- Phase
- Interventional
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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- childbearing age (15-49 years);
- origin from Schistosoma -endemic country;
- presence of at least one of the following symptoms compatible with FGS: abnormal vaginal discharge, vaginal spotting/bleeding, genital itching or burning sensation, pelvic pain/dyspareunia, genital ulcers, macrohematuria, subfertility/infertility, miscarriage and/or extrauterine pregnancy, unexplained anemia, menstrual irregularities, previous birth of a premature/low birth weight fetus or growth retarded baby;
- Informed consent to study participation and to personal data's treatment.
Who cannot join
- Deny of informed consent to study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Tamara Ursini, +390456013226, tamara.ursini@sacrocuore.it
About this study
The aim of this study is to evaluate the prevalence of female genital schistosomiasis (FGS) in the migrant population with gynecological problems who access our center's dedicated outpatient clinic. Furthermore, we will address the relevance of FGS in women with clinical manifestations of the upper genital tract and evaluate the role of cervical-vaginal swabs in predicting upper genital tract involvement in schistosomiasis infection.
The study is classified as experimental despite its descriptive objective of the prevalence of the infection of interest, as the vaginal swab and the PCR test performed on the swab and, if necessary, on the histological sample (collected during a possible interventional procedure performed for the patient's clinical needs) are not part of the standard clinical management of these cases but will be performed for the purposes of the study.
- Conditions
- Female Genital Schistosomiasis
- Being tested
- Cervical-vaginal swab
- Keywords
- female, genital, schistosomiasis
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical-vaginal swabProcedure or surgery
One cervical-vaginal swab will be collected by the gynecologist and will be sent to the parasitology laboratory of DITM for molecular detection of Schistosoma spp DNA using in-house real-time PCR.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Women diagnosed with schistosomiasis and complaining gynecological symptoms will be referred to the gynecologist. Upon gynecological evaluation, informed consent to enrolment in the study will be sought. If necessary, cultural mediation will be requested for the collection of consent.
One cervical-vaginal swab will be collected by the gynecologist, being specifically performed for the study purpose. For patients requiring hysteroscopy, hysterectomy or other procedures entailing collection/removal of endometrial tissue, part of retrieved biological material will be collected for molecular analysis. During the hysteroscopic examination/hysterectomy/revision of uterine cavity, bioptic samples will be collected as per standard procedure, part of which will be used for routine histological examination at the pathological anatomy department, and the leftover will be sent to the parasitology laboratory for molecular detection of Schistosoma spp DNA using in-house real-time PCR. Receives: Procedure: Cervical-vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Genital Schistosomiasis (FGS)
Proportion of FGS cases, defined as women with the given symptoms/signs and positive real-time PCR on cervical-vaginal swab and/or biopsy over the total number of women tested.
Measured: At baseline
Secondary outcomes (1)
Signs/symptoms
Frequency of specific signs/symptoms (Y/N) in patients diagnosed with FGS:
- abnormal vaginal discharge
- vaginal spotting/bleeding
- genital itching or burning sensation
- pelvic pain/dyspareunia
- genital ulcers
- macrohematuria
- subfertility/infertility
- miscarriage and/or extrauterine pregnancy
- unexplained anemia
- menstrual irregularities
- previous birth of a premature/low birth weight fetus or growth retarded baby -histopathological features (presence of Schistosoma eggs in female genital tissues),
- UGT involvement
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start20 Feb 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484256
- Sponsor's protocol ID
- 2024-29
- Acronym
- MATCHING
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No