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IRCT20160524028038N12 IRCT 2022-12-02 Bandare-abbas University of Medical Sciences Indomethacin and fertility outcomes in infertile women with poor ovarian response Comparison of the effect of indomethacin compared to not receiving indomethacin on fertility outcomes in infertile women with poor ovarian response under assisted reproductive treatment 2022-11-26 anticipated 60 Complete https://irct.ir/trial/66886 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 and B) for the allocation of subjects to intervention (A) and control (B) groups will be used. 3 Female infertility due to poor ovarian response. Intervention 1: First, patients will receive 300 units of Gonal F ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of Human chorionic gonadotropin will be injected. Patients in the intervention group will receive indomethacin (100 mg) rectal suppositories 12 hours apart and then 24 hours after the initial trigger. Intervention 2: First, patients will receive 300 units of Gonal F recombinant FSH ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of HCG will be injected. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Associate professor
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
Bandarabbas Iran (Islamic Republic of) 7916839319 076333666365 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences scientific Maryam Azizi
Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan
Bandarabbas Iran (Islamic Republic of) 7916839319 076333666365 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 45 years Absence of contraindications to the use of indomethacin Normal semen analysis poor ovarian response 18 years 45 years Female Patients with other endocrine disorders such as hyperprolactinemia, PCOS, etc. History of ovarian surgery or ovarian endometrioma Smoker Cardiovascular disorders Receiving drugs affecting the metabolism of indomethacin Unwillingness to cooperate History of peptic ulcer or recurrent active gastric ulcer History of gastrointestinal lesions Allergy to indomethacin or any of the ingredients of this product History of acute attacks of asthma, urticaria, or rhinitis as a result of treatment with aspirin or other non-steroidal anti-inflammatory drugs. Drug abuse History of proctitis or recent rectal bleeding Having nasal polyps with angioneurotic edema N97.8 Female infertility of other origin Treatment - Drugs Treatment - Drugs First, patients will receive 300 units of Gonal F ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of Human chorionic gonadotropin will be injected. Patients in the intervention group will receive indomethacin (100 mg) rectal suppositories 12 hours apart and then 24 hours after the initial trigger. First, patients will receive 300 units of Gonal F recombinant FSH ampoule and 150 units of human monoposal gonadotropin daily for 4 days from the second day of menstruation. Gonadotropin dose will be adjusted according to ovarian response in transvaginal ultrasound and serum estradiol concentration from day 5 of stimulation. Ultrasound will be done on the sixth day when we have at least one more follicle equal to 13. Citrotriad will start with the flexible protocol. We continue the treatment until the follicle reaches 17 mm. If the patient has more than 2 follicles of 16 mm, the trigger will be performed and 10,000 units of HCG will be injected. Oocyte Quality. Timepoint: 2-3 hrs. after oocyte collection. Method of measurement: Microscopic Evaluation. Number of retried oocyte. Timepoint: On day of oocyte retrieval. Method of measurement: Counting number of total oocytes with microscope. Number of embryo. Timepoint: On the 2nd day after ICSI. Method of measurement: Observation with microscope. Bandare-abbas University of Medical Sciences Approved 2022-07-25 Ethics committee of Hormozgan University of Medical Sciences Vice chancellor of research, Shahid Mohamadi Hospital, Bandarabbas, Hormozgan Bandarabbas Hormozgan Iran (Islamic Republic of)