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IRCT20210313050688N1 IRCT 2021-05-17 Ardabil University of Medical Sciences ٍEffect of Sildenafil and estradiol valerate on increasing endometrial thickness The effect of Sildenafil and estradiol valerate on increasing endometrial thickness before intra uterine insemination 2021-05-22 anticipated 100 Complete https://irct.ir/trial/55920 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be enrolled randomly in to one of the groups based on inclusion criteria. Randomisation sequence will be processed by Microsoft Excel program via (RANDBETWEEN) command and numbers 0 and 1 will be allocated to each group to choose the group of the subject, Blinding description: Viagra and placebo tablets are indistinguishable for patients and can not be recognised by their appearance. 2-3 Female infertility due to nonimplantation of ovum. Intervention 1: Control group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Placebo gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed. Intervention 2: Intervention group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Viagra gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed. Yes - There is a plan to make this available What will be shared: Only data related to outcomes wil be shared When: Data will be accessible from 21 march 2022 onward To whom: Data will be accessible from 21 march 2021 onward Conditions: No restrictions on data analysis after data is shared Where to obtain: Dr Faranak Jalilvand How to obtain: All requests should be sent to the email address f.jalilvand@arums.ac.ir and will be responded in 2 weeks time Comments:
public Dr Faranak Jalilvand
Alavi hospital, Maadi st., Saheli st.
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3324 8888 f.jalilvand@arums.ac.ir Ardabil University of Medical Sciences scientific Dr Faranak Jalilvand
Alavi hospital, Maadi st., Saheli st.
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3324 8888 f.jalilvand@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Patients with infertility due to a decreased endometrial thickness Age between 20 to 35 years old BMI lower than 30 kg per square meters 20 years 35 years Female Women with congenital uterine abnormality or acquired deformity of uterine tube wich interferes with implantation Women with tubal infertility Women with contraindication to estrogen therapy (CVA or DVT history and benign hepatic diseases) Women wich have a male factor infertility (Aospermia , Teratospermia, ...) N97.2 Female infertility of uterine origin Placebo Treatment - Drugs Control group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Placebo gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed. Intervention group: Patients of this group will receive An Estradiol valerate tablet every 12 hours from the 10th day of menstruation to the initiation of ovulation(10days) and also, they will receive Viagra gel vaginally from days 9 to 12 of the menstruation (up to 4 days). To evaluate endometrial thickness, patients will undergo vaginal sonography before initiation of treatment and 9 days after the treatment is completed. Endometrial thickness. Timepoint: Based on the reported sonographic result 9 days after initiation of treatment. Method of measurement: Transvaginal Ultrasound. Ardabil University of Medical Sciences Approved 2020-12-07 Ethics committee of Ardabil University of Medical Sciences Deputy of research and technology, Northern side of Ardabil university of medical sciences, Daneshgah sq., Daneshgah st Ardabil Ardabil Iran (Islamic Republic of)