[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-dysbiosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-dysbiosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100627779","phase-2-effect-of-fb301-on-vaginal-bacterial-profile-in-women-with-asymptomatic-vaginal-dysbiosis-undergoing-a-mock-frozen-embryo-transfer-cycle-100627779",false,"NCT07453069","Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle","A Randomized, Double-blind, Three Arm, Multi-center Phase 2 Study to Investigate the Molecular Efficacy and Safety of FB301\u002FChlorhexidine Compared With FB301\u002FSham and Placebo\u002FSham in a Mock FET Cycle in Female Participants 18-40 Years of Age With Asymptomatic Vaginal Molecular Dysbiosis Planning to Undergo a Frozen Embryo Transfer (FET) Cycle","Inclusion Criteria:\n\n1. Able to understand the study and sign a consent form.\n2. Is a woman aged 18 to 40 years.\n3. Still has regular menstrual periods (pre-menopausal).\n4. Has had at least one previous frozen embryo transfer (FET) that did not result in pregnancy within the past 3 years, and this was not due to either male infertility or blocked \u002Fdamaged fallopian tubes.\n5. Planning to have a frozen embryo transfer (FET) using one good-quality embryo (grade 3BB or higher) and are considered medically suitable to proceed.\n6. Willing to have only one embryo transferred during the study cycle.\n7. A vaginal swab taken at the first study visit shows a specific vaginal microbiome imbalance required for this study (vaginal molecular dysbiosis).\n8. An ultrasound scan shows no problems with uterus or pelvis that would prevent pregnancy or greatly reduce the chance of pregnancy.\n9. Recent fertility blood tests (within the last 6 months) show:\n\n   * FSH less than 12 IU\u002FL\n   * AMH greater than 1 ng\u002FmL\n10. Body mass index (BMI) is between 18 and 38 kg\u002Fm².\n11. From the first study treatment until the mock FET cycle, agrees to:\n\n    * Avoid vaginal intercourse or use condoms (without spermicide or lubricant),\n    * Avoid swimming or hot tubs,\n    * Avoid using tampons, menstrual cups, sex toys, vaginal cleansers, lubricants, or other vaginal products unless approved by the study team.\n12. Willing to answer questions about sexual and reproductive activity during the study.\n13. Willing to provide vaginal swab samples at the clinic.\n14. Willing to receive the first study treatment in the clinic and use the study treatment at home as instructed.\n15. Screening blood tests are negative for hepatitis B, hepatitis C, HIV, and syphilis.\n16. Willing to attend all study visits and follow-up assessments and provide information about pregnancy and newborn health outcomes.\n\nExclusion Criteria:\n\n1. History of three or more failed frozen embryo transfers (FET) in the past 3 years.\n2. Have a condition that weakens the immune system (such as uncontrolled diabetes, active cancer, or an organ transplant).\n3. Currently taking medications that suppress the immune system (such as systemic steroids, biologics, chemotherapy, or transplant medications).\n4. Is already pregnant before completing the mock FET cycle.\n5. Test positive for a sexually transmitted infection (such as chlamydia, gonorrhea, Mycoplasma genitalium, or Trichomonas vaginalis).\n6. Current vaginal yeast infection that requires treatment.\n7. YCannot safely take the hormone medications required for a frozen embryo transfer (such as estradiol or progesterone).\n8. Use of intravaginal progesterone gels or solutions.\n9. Needs regular antibiotics or are likely to require antibiotics during the study.\n10. Has taken oral, injectable, or vaginal antibiotics within 30 days before screening.\n11. History of gynecological cancer or other significant gynecological condition that would make participation unsafe.\n12. Has a medical condition that would make participation unsafe or difficult.\n13. Has an unstable medical or psychiatric condition that could make it difficult to follow study requirements.\n14. Has any other condition that could interfere with participation.","FEMALE","18 Years","40 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).\n\nThe main question it aims to answer is:\n\n• Does treatment with FB301 during a mock FET cycle change the proportion of participants who meet the predefined vaginal bacterial threshold compared with placebo?\n\nResearchers will compare:\n\n* FB301 given after an initial vaginal cleansing with chlorhexidine (an antiseptic solution),\n* FB301 given after an initial vaginal cleansing with saline (saltwater), and\n* A placebo capsule given after an initial vaginal cleansing with saline to determine whether these approaches affect vaginal bacterial composition and pregnancy outcomes.\n\nParticipants will take study treatment for 15 days during a \"mock\" FET cycle. In a mock cycle, participants receive the hormones needed to prepare the uterus for embryo transfer, but no embryo is transferred. After completing the mock cycle, participants will proceed with their planned frozen embryo transfer and will be followed during pregnancy until birth.\n\nParticipants will:\n\n* Undergo a vaginal cleansing before receiving the first dose of FB301 or placebo\n* Provide vaginal swab samples at up to 5 study visits\n* Attend the study centre for up to 8 visits and participate in up to 4 follow-up phone calls\n* Complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle\n\nParticipants who become pregnant will be followed until birth.",[27],"Vaginal Dysbiosis","NOT_YET_RECRUITING","2026-03-03",{"date":31,"type":32},"2026-03-05","ACTUAL",{"date":34,"type":21},"2026-04-15",{"date":36,"type":21},"2027-09-30",{"name":38,"class":39},"Freya Biosciences ApS","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100567424","a-multicenter-open-comparative-study-on-vaginal-dysbiosis-in-premenopausal-women-dispaloma-100567424","NCT06668012","A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)","A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)","DISPALOMA","Inclusion Criteria:\n\n1. Between 18 and 45 years of age, inclusive.\n2. Who are attending a gynecological visit for any reason and who are in the first phase of the menstrual cycle, between the end of menstruation and before ovulation (approximately between days 9 and 15).\n3. With regular menstrual cycles of between 24 and 35 days.\n4. Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them.\n5. With a vaginal pH higher than 4.5 with or without symptoms\n\nExclusion Criteria:\n\n1. Diagnosis of another vaginal or vulvar condition that may confuse the interpretation of the response to the investigational product (erosive lichen planus, inflammatory desquamative vaginitis, or contact dermatitis involving the vulvar epithelium).\n2. Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.\n3. Active genitourinary infections (VVC, N. gonorrhoeae, C. trachomatis, or T. vaginalis) at the time of inclusion or within 15 days prior to inclusion in the study.\n4. Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.\n5. Pregnant patients or in the immediate postpartum period (up to 40 days).\n6. Contraception with copper IUD.\n7. Use of oral or topical antibiotics, or vaginal antifungals in the two weeks prior to the initial visit.\n8. Planned immunosuppressive therapy.\n9. Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.).\n10. Use of any other experimental drug or device during the 30 days prior to selection.\n11. Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatments.\n12. Inability, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems or due to psychophysical characteristics.","45 Years",{"count":20,"type":21},[52],"NA","The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.",[27],[56,57,58],"Vaginal","Palomacare","Dysbiosis","RECRUITING","2025-01-30",{"date":62,"type":32},"2025-02-03",{"date":64,"type":32},"2024-12-12",{"date":66,"type":21},"2025-05-31",{"name":68,"class":39},"Procare Health Iberia S.L.",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100542919","phase-4-screen-and-treat-strategy-for-vaginal-flora-abnormalities-in-pregnant-women-at-high-risk-of-preterm-birth-100542919","NCT06349122","Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth","Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2)","AUTOP2","Inclusion Criteria:\n\n* Pregnant women over 18 years of age\n* Pregnant woman after 8 weeks and before 18 weeks of gestation (i.e. \\>=8 weeks and ≤ 18 weeks)\n* Woman who has understood the study process and objectives and agreed to sign an informed consent form;\n* With a history of preterm birth before 37 weeks of gestation or late miscarriage (high-risk preterm birth population) (A late miscarriage or late fetal loss mean foetal loss between 14 and 22 weeks of gestation)\n* Affiliated to a social security regimen or equivalent\n\nExclusion Criteria:\n\n* \\- Woman of legal age under legal protection;\n* Women deprived of their freedom for administrative or legal reasons;\n* Woman who has not signed a consent form\n* Nulliparous;\n* Ectopic pregnancy;\n* Non-evolutive pregnancy or IUFD\n* Multiple pregnancy\n* Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly.\n* Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study\n* Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients\n* Woman presenting uterine malformation ( unicornuate, bicornuate, full septate)\n* Woman with preterm birth history because of twin pregnancy\n* Woman having received anti-infective treatment in the week preceding inclusion",{"count":79,"type":21},1292,[81],"PHASE4","Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis.\n\nThe main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth.\n\nThe hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.",[84,27,85],"Bacterial Vaginosis","Premature Delivery",[87],"screen and treat strategy","2024-03-29",{"date":90,"type":32},"2024-04-05",{"date":92,"type":21},"2024-08",{"date":94,"type":21},"2028-01",{"name":96,"class":97},"Assistance Publique Hopitaux De Marseille","OTHER"]