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IRCT2016112331052N1 IRCT 2017-03-08 Avicenna Research Center The Randomised Uterine Septum Transsection Trial To assess whether hysteroscopic metroplasty will improve reproductive outcome in infertile women with a septate uterus and an active wish to conceive 2017-01-20 anticipated 68 Complete https://irct.ir/trial/24505 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment. N/A Septated Uterus. Intervention 1: Intervention: Hysteroscopic metroplasty in patients who have septated uterus and wishing to have pregnancy. In patients with uterine septum and wishing to have pregnancy, hysteroscopic uterine septum resection will be done. Intervention 2: Control: women with wishing to pregnancy and having septated uterus but we will not perform hysteroscopic septum resection for them.
public Roya Padmehr
Avicenna infertility center,Yakhchal street, Shariati avenue
Tehran Iran (Islamic Republic of) 1936773493 +98 21 23519 r.padmehr@ari.ir Avicenna research center scientific Roya Padmehr
Avicenna infertility center, Yakhchal street, Shariati avenue
Tehran Iran (Islamic Republic of) 1936773493 +98 21 23519 r.padmehr@ari.ir k.shadjoo@ari.ir Avicenna research center Iran (Islamic Republic of) Inclusion criteria: Infertile women who visited in Avicenna Research center and 6 medical centers in netherland ; The trial will include women with a septate uterus and an active wish to conceive. A septate uterus is defined as a uterus with a division (septum) of the uterine cavity, without any restrictions to the length of the septum. The external contour of the uterus should not have an indentation; Having satiafaction about participating in this study . Exclusion criteria:Women with contraindication for surgery 15 years 45 years Female q51.9 Congenital malformation of uterus and cervix, unspecified Treatment - Surgery N/A Intervention: Hysteroscopic metroplasty in patients who have septated uterus and wishing to have pregnancy. In patients with uterine septum and wishing to have pregnancy, hysteroscopic uterine septum resection will be done. Control: women with wishing to pregnancy and having septated uterus but we will not perform hysteroscopic septum resection for them. Live birth after 24 weeks pregnancy. Timepoint: Live birth at least 24 weeks of gestational age within one year after surgery. Method of measurement: Sonography and clinical visits and notes. Uterine perforation during intervetion. Timepoint: During hysteroscopic metroplasty of septated uterus. Method of measurement: Clinical findings,hysteroscopic findings,sonographic findings. Abortion. Timepoint: Within one year of intervention. Method of measurement: Clinical findings. Week of pregnancy that abortion occured. Timepoint: Within 1 years after intervention. Method of measurement: Week of pregnancy. Uterine perforation in pregnancy after intervention. Timepoint: During pregnancy within one year of intervention. Method of measurement: Clinical findings. Preterm labor. Timepoint: Within one year of intervention. Method of measurement: Weeks of pregnancy. Clinical pregnancy. Timepoint: Within1 years after intervention. Method of measurement: Sonography. Endometritis. Timepoint: Till 6 weeks after intervention. Method of measurement: Clinical findings. Maternal death during pregnancy. Timepoint: Within one year after intervention. Method of measurement: Clinical findings. Avicenna Research Center Approved 2016-10-30 Avicenna Research Center Avicenna Research Center, Shahid Beheshti University Tehran Iran (Islamic Republic of)