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Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hystroscope
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Unexplained Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. All women aged (20-35) years old. 2. Unexplained infertility

Exclusion Criteria:

  • 1. Female genital tract cancer, including cervical or uterine cancer 2. Active pelvic infection 3. Known uterine factor for infertility.

Sites / Locations

  • Department of obstetrics and gynaecology, faculty of medicine, Ain shams universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Undergoing Hysterosopy

Arm Description

This group will include 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle.

Outcomes

Primary Outcome Measures

Pregnancy
Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2017
Last Updated
April 1, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03380364
Brief Title
Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility
Official Title
Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this work is to assess the value of hysteroscopy in unexplained infertility.
Detailed Description
The diagnosis of unexplained infertility is one of exclusion and is made only after an infertility evaluation has failed to reveal abnormalities. There is no consensus on which tests should be performed before making this diagnosis (Salim et al., 2011). The Europe society for human and embryology (ESHRE) suggested standard diagnostic tests for infertility evaluation. These tests include semen analysis, demonstration of tubal patency by hystosalpingography (HSG) or laparascopy and laboratory assessment of ovulation (Polisseni et al., 2003). Moreover post coital test has been included by some authors as a fundamental requirement before the diagnosis of unexplained infertility while other authors found that it is unnecessary however conducting additional investigation and treating any abnormalities detected may be effective in management of women with unexplained infertility especially in older couples (Wortman et al., 2013). For evaluation of the uterine cavity, the basic work-up consists of transvaginal sonography (TVS) with or without the use of saline or gel as a contrast medium, possibly followed by either HSG or hysteroscopy to directly assess the uterine cavity. Both TVS, as well as saline infusion sonography (SIS) and gel instillation sonography (GIS) are inexpensive, non-invasive and have been shown to be excellent diagnostic tool to detect subtle intrauterine abnormalities (Rodrigues et al., 2014). However, hysteroscopy allows direct visualization of the endometrial lining and detects multiple lesions and subtle uterine abnormalities that cannot be identified by the previous techniques. Moreover, hysteroscopy enables treatment of small uterine pathology in the same setting. Therefore, it is frequently referred to as the golden standard. Many studies have concluded that whenever laparoscopy is performed, it should be combined with hysteroscopy in order to complete the assessment before starting the infertility treatment (Chan et al., 2011). In the assisted reproductive technique, a number of studies was conducted on women before in vitro fertilization (IVF) cycle revealed that the prevalence of un suspected intra uterine abnormalities, diagnosed by hysteroscopy prior to IVF cycles was 11% - 45% (Shokeir et al., 2011). Although the role of these subtle lesions as a cause of infertility is debatable,( Kilic et al., 2013) hysteroscopic assessment and treatment of any abnormalities detected has improved the clinical pregnancy rate , live birth, and considered cost effective before IVF cycles (Grimbizis et al., 2003) . It is widely accepted that a complete infertility workup includes an evaluation of the uterine cavity (Chan et al., 2011). Uterine abnormalities, congenital or acquired, are implicated as one of the causes of infertility. In fact, infertility related to uterine cavity abnormalities has been estimated to be the causal factor in as many as 10% to 15% of couples seeking treatment (Romani et al. 2013). Hysteroscopy enables visualisation of the uterine cavity and allows the diagnosis and surgical treatment of intrauterine pathology. (Umranikar et al., 2016). Direct view of uterine cavity offers a significant advantage over other blind or indirect diagnostic methods. Although , hystrosalpingography (HSG) is reported to be as accurate as hysteroscopy in the diagnosis of normal and abnormal cavities, the nature of intrauterine filling defects is more accurately revealed by hysteroscopy (Jenneke et al.,2013). The role of hysteroscopy in infertility investigation is to detect possible intrauterine change that could interfere with implantation or growth, or both, of the conceptus (Scholten et al., 2013) and to evaluate the benefit of direct treatment modalities in restoring a normal endometrial environment (Prasanta et al., 2013). Several studies have been also performed to find out that if hystroscopic treatment of intrauterine pathologies increases the cause of failure of IVF-ET (Fatemi et al., 2010) and therefore hysteroscopy should be a part of infertility workup for all patients prior to undergoing IVF treatment and have also recommended screening of the uterus by hysteroscopy before proceeding with IVF/ICSI, to minimize implantation failure (Ryan et al. 2005). The potential risk of diagnostic hysteroscopy are rare in most series (0-1%) especially in office procedure (John et al., 2013), while (5-24%) of operative cessions may result in intraoperative or early postoperative complications which include infection, bleeding, and even perforation of the uterus. Certain factors are considered contraindication to hystroscope like PID (Aydeniz et al., 2004).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Undergoing Hysterosopy
Arm Type
Experimental
Arm Description
This group will include 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle.
Intervention Type
Device
Intervention Name(s)
hystroscope
Intervention Description
Procedure: Hysteroscopy Office hysteroscopy will be performed during the proliferative phaseof the 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 Name: ROH: Routine Office Hysteroscopy Device: Hysteroscope The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 5-mm diameter diagnostic rigid 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
Primary Outcome Measure Information:
Title
Pregnancy
Description
Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. All women aged (20-35) years old. 2. Unexplained infertility Exclusion Criteria: 1. Female genital tract cancer, including cervical or uterine cancer 2. Active pelvic infection 3. Known uterine factor for infertility.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan H EL Khateeb, MS
Phone
00201008834646
Email
drsamehhabib@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Y Mansour, PhD
Phone
00201006575414
Email
dinayahiamansour@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Al helaly, PhD
Organizational Affiliation
Ain Shams University (Obs&Gyn)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kaled S Mohamed, PhD
Organizational Affiliation
Ain Shams University (Obs&Gyn)
Official's Role
Study Chair
Facility Information:
Facility Name
Department of obstetrics and gynaecology, faculty of medicine, Ain shams university
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HANAN H EL KHATEEB, MS
Phone
201008834646
Email
drsamehhabib@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12206931
Citation
Aydeniz B, Gruber IV, Schauf B, Kurek R, Meyer A, Wallwiener D. A multicenter survey of complications associated with 21,676 operative hysteroscopies. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):160-4. doi: 10.1016/s0301-2115(02)00106-9.
Results Reference
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PubMed Identifier
21705770
Citation
Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.
Results Reference
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PubMed Identifier
21830244
Citation
Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
Results Reference
result
PubMed Identifier
20570971
Citation
Fatemi HM, Kasius JC, Timmermans A, van Disseldorp J, Fauser BC, Devroey P, Broekmans FJ. Prevalence of unsuspected uterine cavity abnormalities diagnosed by office hysteroscopy prior to in vitro fertilization. Hum Reprod. 2010 Aug;25(8):1959-65. doi: 10.1093/humrep/deq150. Epub 2010 Jun 22.
Results Reference
result
PubMed Identifier
11284660
Citation
Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update. 2001 Mar-Apr;7(2):161-74. doi: 10.1093/humupd/7.2.161.
Results Reference
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PubMed Identifier
23602685
Citation
Kasius JC, Eijkemans RJ, Mol BW, Fauser BC, Fatemi HM, Broekmans FJ. Cost-effectiveness of hysteroscopy screening for infertile women. Reprod Biomed Online. 2013 Jun;26(6):619-26. doi: 10.1016/j.rbmo.2013.02.015. Epub 2013 Mar 14.
Results Reference
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PubMed Identifier
24286992
Citation
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Results Reference
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PubMed Identifier
23053317
Citation
Kilic Y, Bastu E, Ergun B. Validity and efficacy of office hysteroscopy before in vitro fertilization treatment. Arch Gynecol Obstet. 2013 Mar;287(3):577-81. doi: 10.1007/s00404-012-2584-z. Epub 2012 Oct 6.
Results Reference
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PubMed Identifier
12904693
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
result

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Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility

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