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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Infertility Unspecified, Infertility, Ovarian Hyperstimulation, Pregnancy

Intervention / Treatment
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* Procedure: Hysteroscopy
* Device: Hysteroscope


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Undergoing Hysterosopy<br>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<br>* 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.<br>* Other names: ROH: Routine Office Hysteroscopy;Device: Hysteroscope<br>* 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<br>|
| No Intervention: Group With No intervention<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Pregnancy | Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks) | 2-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization