Hysteroscopic Isthmocele Repair on IVF Outcome

Cesarean Section; Dehiscence Clinical Trial

Official title:

Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590104
• Other study ID #: HIROIO
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2023
• Source: HealthPlus Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.

Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.

Description:

Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle.

Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.

Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Diagnosed CS scar defect by TVUS

• At least one failed trial of euploid embryo transfer

• Planning for a trial of single euploid embryo transfer

Exclusion Criteria:

• Residual myometrial thickness less than 3 mm

• Any congenital uterine abnormalities.,

• Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence
• Intrauterine Disorder
• Reproductive Issues

Intervention

Procedure:
• Hysteroscopic CS scar defect repair
Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis.

Locations

Country	Name	City	State
United Arab Emirates	Healthplus fertility center	Abu Dhabi	UAE
United Arab Emirates	Healthplus fertility center	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
HealthPlus Fertility Center

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Clinical pregnancy	detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan	at 7 weeks of gestation or beyond
Secondary	Rate of Complications following hysteroscopic CS scar repair	uterine perforation, fluid overload and endometritis	up to 6 weeks
Secondary	Rate of Need of aspiration of intrauterine fluid	Presence intrauterine fluid collection at the time of embryo transfer which should be aspirated before embryo transfer	During the preparation of embryo transfer. Through study completion, an average of 1 year
Secondary	Rate of Early pregnancy complications	Ectopic pregnancy or Miscarriage	12 weeks gestation
Secondary	Rate of Caesarean section scar dehiscence or rupture	Rupture of CS scar during the antenatal period or presence of CS scar wound dehiscence at the time of delivery	Within 40 weeks of pregnancy
Secondary	Rate of delivery of a living baby	Delivery of a living baby after 24 weeks gestation	Within 40 weeks of pregnancy