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

Not Applicable

• Conditions: Ovarian Hyperstimulation; Primary Infertility Unspecified; Infertility; Pregnancy
• Interventions: Procedure: Hysteroscopy; Device: Hysteroscope

• Registration Number: NCT02416596
• Lead Sponsor: Ain Shams Maternity Hospital

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.

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 Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-10
• Last Update Submitted: 2015-04-10
• Study First Posted: 2015-04-15
• Last Update Posted: 2015-04-15
• Study Start: 2016-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 680

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Undergoing Hysterosopy	Hysteroscope	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.
Group Undergoing Hysterosopy	Hysteroscopy	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.

Primary Outcome Measures

Name	Time	Method
Biochemical Pregnancy	2-6 weeks	Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)