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

Primary Purpose

Primary Infertility Unspecified, Infertility, Ovarian Hyperstimulation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hysteroscopy
Hysteroscope
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Infertility Unspecified focused on measuring ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group Undergoing Hysterosopy

    Group With No intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2015
    Last Updated
    April 10, 2015
    Sponsor
    Ain Shams Maternity Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02416596
    Brief Title
    Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility
    Official Title
    Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Infertility Unspecified, Infertility, Ovarian Hyperstimulation, Pregnancy
    Keywords
    ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    680 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Undergoing Hysterosopy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group With No intervention
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hysteroscopy
    Other Intervention Name(s)
    ROH: Routine Office Hysteroscopy
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Hysteroscope
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Biochemical Pregnancy
    Description
    Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)
    Time Frame
    2-6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr A. Abdulreheem, MBBCh
    Phone
    +201006774459
    Email
    amro984@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moustafa F Gomaa, PhD
    Phone
    01226188993
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khaled H Swaydan, PhD
    Organizational Affiliation
    Ain Shams University (Obs&Gyn)
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed K Mekled, PhD
    Organizational Affiliation
    Ain Shams University (Obs&Gyn)
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18492377
    Citation
    El-Toukhy T, Sunkara SK, Coomarasamy A, Grace J, Khalaf Y. Outpatient hysteroscopy and subsequent IVF cycle outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2008 May;16(5):712-9. doi: 10.1016/s1472-6483(10)60486-5.
    Results Reference
    background
    PubMed Identifier
    24365027
    Citation
    Pundir J, Pundir V, Omanwa K, Khalaf Y, El-Toukhy T. Hysteroscopy prior to the first IVF cycle: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Feb;28(2):151-61. doi: 10.1016/j.rbmo.2013.09.025. Epub 2013 Oct 5.
    Results Reference
    background
    PubMed Identifier
    11728660
    Citation
    Loverro G, Nappi L, Vicino M, Carriero C, Vimercati A, Selvaggi L. Uterine cavity assessment in infertile women: comparison of transvaginal sonography and hysteroscopy. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):67-71. doi: 10.1016/s0301-2115(01)00434-1.
    Results Reference
    background
    PubMed Identifier
    22818094
    Citation
    Karayalcin R, Ozyer S, Ozcan S, Uzunlar O, Gurlek B, Moraloglu O, Batioglu S. Office hysteroscopy improves pregnancy rates following IVF. Reprod Biomed Online. 2012 Sep;25(3):261-6. doi: 10.1016/j.rbmo.2012.05.013. Epub 2012 Jun 16.
    Results Reference
    background
    PubMed Identifier
    17481803
    Citation
    De Placido G, Clarizia R, Cadente C, Castaldo G, Romano C, Mollo A, Alviggi C, Conforti S. Compliance and diagnostic efficacy of mini-hysteroscopy versus traditional hysteroscopy in infertility investigation. Eur J Obstet Gynecol Reprod Biol. 2007 Nov;135(1):83-7. doi: 10.1016/j.ejogrb.2007.02.028. Epub 2007 May 3.
    Results Reference
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    PubMed Identifier
    20171615
    Citation
    Almog B, Shalom-Paz E, Dufort D, Tulandi T. Promoting implantation by local injury to the endometrium. Fertil Steril. 2010 Nov;94(6):2026-9. doi: 10.1016/j.fertnstert.2009.12.075. Epub 2010 Feb 19.
    Results Reference
    background
    PubMed Identifier
    12798877
    Citation
    Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
    Results Reference
    background
    PubMed Identifier
    19744944
    Citation
    Bosteels J, Weyers S, Puttemans P, Panayotidis C, Van Herendael B, Gomel V, Mol BW, Mathieu C, D'Hooghe T. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Hum Reprod Update. 2010 Jan-Feb;16(1):1-11. doi: 10.1093/humupd/dmp033.
    Results Reference
    background
    PubMed Identifier
    25498596
    Citation
    Huang LN, Tan J, Hitkari J, Dahan MH. Should IVF be used as first-line treatment or as a last resort? A debate presented at the 2013 Canadian Fertility and Andrology Society meeting. Reprod Biomed Online. 2015 Feb;30(2):128-36. doi: 10.1016/j.rbmo.2014.10.004. Epub 2014 Oct 14.
    Results Reference
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    PubMed Identifier
    20091498
    Citation
    Hughes E, Brown J, Collins JJ, Vanderkerchove P. Clomiphene citrate for unexplained subfertility in women. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000057. doi: 10.1002/14651858.CD000057.pub2.
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    PubMed Identifier
    17709558
    Citation
    Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167.
    Results Reference
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    Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

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