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IRCT20090912002445N8 IRCT 2019-07-31 Shiraz University of Medical Sciences Effects of prostaglandin and clomiphene citrate on pregnancy outcome Adding Prostaglandin to Clomiphene Citrate in Mild Ovarian Stimulation Protocol in those Undergoing Intrauterine Insemination; A Randomized, Double-Blind, Clinical Trial 2018-05-22 anticipated 106 Complete https://irct.ir/trial/40919 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the patients will be randomized into two study groups using a computer-based random digit generator utilizing the patients; registration numbers, Blinding description: Medications and placebo will be prepared in the same capsules. Those giving the intervention, the patients, those recording the study outcomes will be blinded to the study groups. Only the statisticians will know the study groups. 3 Infertility. Intervention 1: Intervention group: Clomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), misoprostol (100mg twice daily from day 5 to 9 of menstrual cycle). Intervention 2: Control group: lomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), placebo (1 capsule twice daily from day 5 to 9 of menstrual cycle). Yes - There is a plan to make this available What will be shared: The baseline, clinical, and outcome measures databases would be available in SPSS format after publication of the study. When: The data will be available immediately after publication of the study. To whom: The data would be to the readers of the published article through the journal's policy and website. Conditions: The is not limitation for accessing the study data after publication. Where to obtain: The database would be available as an appendix to the published article. How to obtain: The database would be available as an appendix to the published article. The availability would be according to the publisher's policy. Comments:
public Pegah Keramati
Ghadir Mother and Child Hospital, Emam Reza Ave.
Shiraz Iran (Islamic Republic of) 7173646199 +98 71 3227 9701 keramati@hotmail.com Shiraz University of Medical Sciences scientific Afsoon Zarei
Ghadir Mother and Child Hospital, Emam Reza Ave.
Shiraz Iran (Islamic Republic of) 7173646199 +98 71332279701 zareia@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with primary and secondary infertility Age between 18 and 45 years Candidates for mild ovarian stimulation and intrauterine insemination (IUI) 18 years 45 years Female Sensitivity to prostaglandins Medical history of hepatic or renal diseases Polycystic ovarian syndrome (PCOS) Not having consent for inclusion in the study N97.4 Female infertility associated with male factors Treatment - Drugs Treatment - Drugs Intervention group: Clomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), misoprostol (100mg twice daily from day 5 to 9 of menstrual cycle). Control group: lomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), placebo (1 capsule twice daily from day 5 to 9 of menstrual cycle). Pregnancy Rate. Timepoint: 14 weeks. Method of measurement: Chemical Beta-HCG test. Number of Dominant Follicle. Timepoint: 14 days. Method of measurement: Transvaginal Sonography. Endometrial thinkness. Timepoint: 14 days. Method of measurement: Transvaginal sonography. Side effects. Timepoint: 1 month. Method of measurement: Adverse effects form. Shiraz University of Medical Sciences Approved 2016-02-12 Ethics Committee of Shiraz University of Medical Sciences Ethics committee office, 7th Floor, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)