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

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02416596

Collaborator

(none)

680

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Infertility Unspecified Infertility Ovarian Hyperstimulation Pregnancy	Procedure: Hysteroscopy Device: Hysteroscope	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

680 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Undergoing Hysterosopy This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle.	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. Other Names: ROH: Routine Office Hysteroscopy 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
No Intervention: Group With No intervention This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle.

Arm

Intervention/Treatment

Experimental: Group Undergoing Hysterosopy

This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle.

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.

Other Names:

ROH: Routine Office Hysteroscopy

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

No Intervention: Group With No intervention

This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle.

Outcome Measures

Primary Outcome Measures

Biochemical Pregnancy [2-6 weeks]
Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
Patients with unexplained primary infertility.

Exclusion Criteria:

Patients undergoing IVF using other protocols of induction.
Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
Other causes of infertility rather than unexplained factor.
Unexplained poor responders during the pending ICSI cycle.
Patients with abnormal findings at hysteroscopy.