Routine office hysteroscopy prior to ICSI and its impact on assisted reproduction program outcome: A randomized controlled trial

Objective: To assess the incidence of undiagnosed intrauterine pathology based on screening office hysteroscopy in women with normal hysterosalpingogram (HSG) and/or transvaginal ultrasonograghy (TVS), and their impact on the success rate of ICSI (intracytoplasmic sperm injection).
Design:Randomized controlled trial.
Setting: In El-Menya Infertility Research and Treatment Center (MIRTC), El-Menya, Egypt.
Patient(s): Two hundred and forty consenting patients were eligible to participate in the study, who further randomized into two equal groups, 120 patients in group I (ICSI without office hysteroscopy), and 120 patients in group II (had ICSI after office hysteroscopy). Only 110 and 105 patients completed the study in group I and group II, respectively.
Intervention(s): ICSI with or without office hysteroscopy.
Main outcome measure(s): Undiagnosed uterine abnormalities, implantation and clinical pregnancy rates.
Result(s): Unsuspected abnormal uterine findings were diagnosed in 35/105 (33.3%) patients with normal HSG and/or TVS among patients in group II by using office hysteroscopy. Implantation rate and clinical pregnancy rate were statistically significant between group I and group II, as clinical pregnancy rate between group I, group IIa (ICSI with normal office hysteroscopy) and group IIb (ICSI with abnormal office hysteroscopy) were 27.2%, 35.7%, 42.8%, respectively (P ≤ 0.05). Among group II 51 patients (48.5%) have repeated IVF or ICSI failure, 23 patients of them (45%) had abnormal hysteroscopy finding and 15 patients (65.2%) achieved pregnancy after correction of their uterine abnormalities. Hysteroscopy has high specificity (88%), high diagnostic accuracy (86.2%) but less sensitivity (80%) in predicting intrauterine abnormalities when compared to HSG and TVS (odd's ratio 1.7, CI 1.33–2.44).
Conclusion(s): The incidence of pathologic abnormalities based on hysteroscopic diagnosis was high especially with repeated IVF failure. Improvement in implantation and clinical pregnancy rates were observed after office hysteroscopy prior to ICS. So routine office hysteroscopy should be an essential step of the infertility workup before ART even in patients with normal HSG and /or TVS.