Hysteroscopic Isthmocele Repair on IVF Outcome

NCT05590104 | Unknown

• 1 other identifier: HIROIO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Reproductive Issues; Cesarean Section; Dehiscence; Intrauterine Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of Complications following hysteroscopic CS scar repair

  up to 6 weeks

• Rate of Need of aspiration of intrauterine fluid

  During the preparation of embryo transfer. Through study completion, an average of 1 year

• Rate of Early pregnancy complications

  12 weeks gestation

• Rate of Caesarean section scar dehiscence or rupture

  Within 40 weeks of pregnancy

• Rate of delivery of a living baby

  Within 40 weeks of pregnancy

Study Arms (2)

Hysteroscopic CS scar defect repair

EXPERIMENTAL

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.

Procedure: Hysteroscopic CS scar defect repair

Expectant management

NO INTERVENTION

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

Interventions

Hysteroscopic CS scar defect repair PROCEDURE

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.

Hysteroscopic CS scar defect repair

Eligibility Criteria

• Age: 25 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed CS scar defect by TVUS
• At least one failed trial of euploid embryo transfer
• Planning for a trial of single euploid embryo transfer

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPlus Fertility Center: lead

Study Sites (2)

Healthplus fertility center

Abu Dhabi, UAE, 11231, United Arab Emirates

RECRUITING

Healthplus fertility center

Abu Dhabi, United Arab Emirates

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocated groups will be concealed in serially-numbered sealed opaque envelops that was only opened just after recruitment. Women in any of the groups will receive the allocated treatment after their approval to participate in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive medicine consultant

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 21, 2022
• Study Start: March 26, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months
• Access Criteria: open

Locations

AE (2)