Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility
NCT ID: NCT02416596
Last Updated: 2015-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
680 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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
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.
No interventions assigned to this group
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
* Patients with unexplained primary infertility.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Amr Abdulreheem
Dr
Principal Investigators
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Khaled H Swaydan, PhD
Role: STUDY_DIRECTOR
Ain Shams University (Obs&Gyn)
Ahmed K Mekled, PhD
Role: STUDY_CHAIR
Ain Shams University (Obs&Gyn)
Central Contacts
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Moustafa F Gomaa, PhD
Role: CONTACT
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167.
Other Identifiers
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ASMH-RH1
Identifier Type: -
Identifier Source: org_study_id
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