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IRCT20160524028038N18 IRCT 2024-01-04 Yasouj University of Medical Sciences Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with polycystic ovary syndrome Evaluation of the effect of Lactofem probiotic supplement on sexual function in patients with different phenotypes of polycystic ovary syndrome undergoing cyproterone compound. 2024-02-09 anticipated 480 Complete https://irct.ir/trial/74794 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent ( A,a,B,b,C,c,D,d) for the allocation of subjects to intervention ( A, B, C, D)and control (a, b, c, d) groups will be used. 3 polycystic ovarian syndrome. Intervention 1: Intervention group: (phenotype A): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months). Intervention 2: Intervention group: (phenotype B): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months). Intervention 3: Intervention group: (phenotype C): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months). Intervention 4: Intervention group: (phenotype D): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months). Intervention 5: Control group (phenotype A): cyproterone compound tablets (21 days per monthly cycle, for 3 months). Intervention 6: Control group (phenotype B): cyproterone compound tablets (21 days per monthly cycle, for 3 months). Intervention 7: Control group (phenotype C): cyproterone compound tablets (21 days per monthly cycle, for 3 months). Intervention 8: Control group (phenotype D): cyproterone compound tablets (21 days per monthly cycle, for 3 months). No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Zahra Asadi
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
Yasuj Iran (Islamic Republic of) 7916839319 +98 917 793 1581 zasadik66@gmail.com Yasouj University of Medical Sciences scientific Zahra Asadi
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
Yasuj Iran (Islamic Republic of) 7916839319 +98 917 793 1581 zasadik66@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) age 18 to 40 years Confirmation of polycystic ovary syndrome based on the Rotterdam criteria Iranian Absence of severe mental conditions since six months before the research Not suffering from severe depression and anxiety according to the depression and anxiety questionnaire No language or cognitive problems preventing the patient from completing the questionnaire No current use of drugs affecting sexual function No smoking Failure to previously diagnose an organic cause for sexual dysfunction by an experienced physician No current use of psychiatric medications Currently taking cyproterone compound tablets as prescribed by the gynecologist 18 years 40 years Female Patients who do not want to cooperate Pregnancy during study E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: (phenotype A): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months) Intervention group: (phenotype B): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months) Intervention group: (phenotype C): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months) Intervention group: (phenotype D): cyproterone compound tablets (21 days in each monthly cycle, for 3 months) along with Lactofem capsules (500 mg, manufactured by Zit-takhammir, Iran, orally, daily, for 3 months) Control group (phenotype A): cyproterone compound tablets (21 days per monthly cycle, for 3 months) Control group (phenotype B): cyproterone compound tablets (21 days per monthly cycle, for 3 months) Control group (phenotype C): cyproterone compound tablets (21 days per monthly cycle, for 3 months) Control group (phenotype D): cyproterone compound tablets (21 days per monthly cycle, for 3 months) Sexual function. Timepoint: Before the intervention and three after the intervention. Method of measurement: FSFI sexual function questionnaire. Yasouj University of Medical Sciences Approved 2023-12-20 Ethics committee of Yasuj University of Medical Sciences No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)