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

• Conditions: Intracytoplasmic Sperm Injection
• Interventions: Procedure: hysteroscopy

• Registration Number: NCT03680690
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-20
• Last Update Submitted: 2018-09-20
• Study First Posted: 2018-09-21
• Last Update Posted: 2018-09-24
• Study Start: 2018-10-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 244

Inclusion Criteria

• Women between 18 and 38 years old.
• An indication for IVF/ICSI.
• Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
• Women with primary or secondary infertility.
• Women with BMI between 20 & 35.

Exclusion Criteria

• Refusal to join the study.
• Untreated tubal hydrosalpinges.
• Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	hysteroscopy	Women with detected or corrected uterine cavitary lesions by hysteroscopy.
Group A	hysteroscopy	women with normal uterus,detected by hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	7th week of pregnancy for cardiac pulsations.	Clinical pregnancy rate Will be evaluated

Secondary Outcome Measures

Name	Time	Method
Abortion rate	up to 28 week	Abortion rate will be observed
Implantation rate	6 weeks	Implantation rate for assessment of implanted embryos
Chemical pregnancy rate Chemical pregnancy rate	4 weeks	Chemical pregnancy rate; Chemical pregnancy rate
Preterm labour rate	9 months	Delivary before term 37 weeks of pregnancy