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IRCT2012070810210N1 IRCT 2013-01-12 Shiraz university of medical sciences Evaluating the Effects of Iatrogenic Endometrial Injury before Performing Intrauterine insemination Evaluating the Effects of Iatrogenic Endometrial Injury before Performing Intrauterine Insemination in Increasing Fertility in Couples Referred to infertility center 2011-03-21 anticipated 144 Complete https://irct.ir/trial/10680 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Infertility and treatment methods. Intervention 1: Group A undergo endometrial biopsy, by a Novak curret biopsy catheter (Neuilly-en-Thelle, France between days 6–8 of previous menstrual cycle before IUI (n=72) and group B (n=72) underwent IUI cycles without undergoing endometrial biopsy. All the patients received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days from the 5th to the 9th day of cycle and highly purified recombinant FSH (Gonal-f, Serono, Hellas, Puregon, Greece) was injected intramuscularly in a dosage of 100 unit/day from the 8th day of the cycle. Then 10000 units of human chorionic gonadotropin (hCG) (Choriomon, IBSA, Switzerland) was injected intramuscularly, if at least one dominant follicles with size of >18mm were seen by transvaginal sonography and serum E2 level was below 2000pg/ml. Intrauterine insemination (IUI) was performed 36 hours after hCG injection . Intervention 2: In the control group no intervention will be done.
public Dr. afsun Zarei
OB & GYN department, Faghihi Hospital, Zand Avenue
Shiraz Iran (Islamic Republic of) Iran +98 71 1233 2365 zareia@sums.ac.ir Shiraz university of medical sciences scientific Dr. Nasrin Dadras
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
Shiraz Iran (Islamic Republic of) Iran +98 71 1646 2610 dadras.nasrin@gmail.com Infertility Research Center Iran (Islamic Republic of) Inclusion criteria: 18–40 years old patients who suffered from unexplained infertility, mild male factor and mild endometriosis; All women had normal plasma concentrations of day 3 LH and FSH; normal tests of renal and hepatic function; normal complete blood counts; normal HSG, laparoscopy and hysteroscopy and negative pregnancy tests. When the endometriosis was diagnosed, the stage was determined according to the revised American society for reproductive medicine classification and the score was recorded. Only those with mild endometriosis were included in the study while those with moderate to severe endometriosis were excluded from the study. Exclusion criteria: hirsutism; autoimmune disorders; endocrinopathies; cirrhosis and other chronic liver diseases; cigarette smoker and/or alcohol abuser (each of the partner); ovarian hyperstimulation syndrome (OHSS ); no desire to continue the program. 18 years 40 years Female N97.9 Female infertility, unspecified Treatment - Other N/A Group A undergo endometrial biopsy, by a Novak curret biopsy catheter (Neuilly-en-Thelle, France between days 6–8 of previous menstrual cycle before IUI (n=72) and group B (n=72) underwent IUI cycles without undergoing endometrial biopsy. All the patients received 100-mg per day clomiphene citrate (Razak Drug Laboratory, Tehran, Iran) for 5 days from the 5th to the 9th day of cycle and highly purified recombinant FSH (Gonal-f, Serono, Hellas, Puregon, Greece) was injected intramuscularly in a dosage of 100 unit/day from the 8th day of the cycle. Then 10000 units of human chorionic gonadotropin (hCG) (Choriomon, IBSA, Switzerland) was injected intramuscularly, if at least one dominant follicles with size of >18mm were seen by transvaginal sonography and serum E2 level was below 2000pg/ml. Intrauterine insemination (IUI) was performed 36 hours after hCG injection . In the control group no intervention will be done. Pregnancy. Timepoint: two weeks after the missed period. Method of measurement: measuring level of blood BhCG by ELISA. Clinical pregnancy. Timepoint: 4 weeks after the missed period. Method of measurement: detecting of intrauterine sac by vaginal sonography. Shiraz university of medical sciences Approved 2011-12-03 Ethics committee of Shiraz University of Medical Sciences 8th Floor, main building of Shiraz University of Medical Sciences, Zand Avenue Shiraz Iran (Islamic Republic of)