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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016112331052N1
Enrollment
68
Registered
2017-03-08
Start date
2017-01-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septated Uterus. Congenital malformation of uterus and cervix, unspecified

Interventions

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
Treatment - Surgery
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
Control: women with wishing to pregnancy and having septated uterus but we will not perform hysteroscopic septum resection for them.

Sponsors

Avicenna Research Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Padmehr

Avicenna research center

r.padmehr@ari.ir+98 21 23519

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026