Hysteroscopic Isthmocele Repair on IVF Outcome

HealthPlus Fertility Center

Status: Enrolling

Conditions: Cesarean Section; Dehiscence; Intrauterine Disorder; Reproductive Issues

Treatments: Procedure: Hysteroscopic CS scar defect repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05590104

HIROIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hysteroscopic CS scar defect repair

Experimental group

Description:

Patient who is randomized to the hysteroscopic repair of CS scar defect will be prepared to have the surgery postmenstrual. The surgery will be under general anasthesia. The participants will be placed in the lithotomy position. The cervix will be visualized using a Sims speculum and grasped using a single-toothed tenaculum, and the cervix, fornix, and vagina will be cleaned. 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. After that the patient will be prepared for another euoploid embryo transfer.

Treatment:

Procedure: Hysteroscopic CS scar defect repair

Expectant management

No Intervention group

Description:

Patient who is randomized to the expectant management will be prepared for another embryo transfer for euoploid embryo.