NCT03680690

Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 244 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

Summary

The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.

Detailed description

Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome. A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected. However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted. An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.

Conditions

• Intracytoplasmic Sperm Injection

Interventions

Type	Name	Description
PROCEDURE	hysteroscopy	office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-30
• Completion: 2020-02-28
• First posted: 2018-09-21
• Last updated: 2018-09-24