NCT02416596

Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

Detailed description

Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit. Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.

Conditions

• Primary Infertility Unspecified
• Infertility
• Ovarian Hyperstimulation
• Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Hysteroscopy	Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle. All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum. Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection.
DEVICE	Hysteroscope	The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy). Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-04-15
• Last updated: 2015-04-15