A septate uterus is a uterine anomaly that affects reproductive outcome.
Women with a septate uterus are at risk for recurrent miscarriage, subfertility and
preterm birth. Resection of the septum is subject of debate. There is no convincing
evidence concerning its effectiveness and safety. This study will assess whether hysteroscopic metroplasty will improve reproductive outcome in women with a septate uterus. This is multicenter randomised controlled trial under the supervision of Academisch Medisch Centrum Amsterdam in which 68 women with a septate uterus with an active wish to conceive are randomly allocated to hysteroscopic metroplasty( intervention group) or expectant management (control group). Primary outcome is live birth defined as the birth of a living foetus beyond 34 weeks of gestation.
Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage,
pregnancy outcomes as placental abruption, uterine rupture, preterm birth and mode
of delivery (vaginal versus caesarean section), perinatal morbidity and mortality and
complications following metroplasty, such as uterine perforation, fluid overload and
endometritis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112331052N1
Registration date:2017-03-08, 1395/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Roya Padmehr
Name of organization / entity
Avicenna Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2351 9390
Email address
r.padmehr@ari.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Research Center
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess whether hysteroscopic metroplasty will improve reproductive outcome in infertile women with a septate uterus and an active wish to conceive
Public title
The Randomised Uterine Septum Transsection Trial
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Center
Street address
Avicenna Research Center, Shahid Beheshti University
City
Tehran
Postal code
1936773493
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
1395.2.IR.ACECR.REC
Health conditions studied
1
Description of health condition studied
Septated Uterus
ICD-10 code
q51.9
ICD-10 code description
Congenital malformation of uterus and cervix, unspecified
Primary outcomes
1
Description
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 outcomes
1
Description
Uterine perforation during intervetion
Timepoint
During hysteroscopic metroplasty of septated uterus
Uterine perforation in pregnancy after intervention
Timepoint
During pregnancy within one year of intervention
Method of measurement
Clinical findings
5
Description
Preterm labor
Timepoint
Within one year of intervention
Method of measurement
Weeks of pregnancy
6
Description
Clinical pregnancy
Timepoint
Within1 years after intervention
Method of measurement
Sonography
7
Description
Endometritis
Timepoint
Till 6 weeks after intervention
Method of measurement
Clinical findings
8
Description
Maternal death during pregnancy
Timepoint
Within one year after intervention
Method of measurement
Clinical findings
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
Control: women with wishing to pregnancy and having septated uterus but we will not perform hysteroscopic septum resection for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Infertility Center
Full name of responsible person
Roya Padmehr
Street address
Avicenna Infertility Center, Yakhchal street, Shariati avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Center
Full name of responsible person
Roya Padmehr
Street address
Avicenna Infertility Center, Yakhchal street, Shariati avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?