Clinical trial NCT02416596: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Infertility Unspecified
Infertility
Ovarian Hyperstimulation
Pregnancy
Keywords: ICSI
IVF
hysteroscopy
Supervision
In-vitro Fertilization
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 680
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Biochemical Pregnancy
timeFrame: 2-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University (Obs&Gyn)
name: Khaled H Swaydan, PhD
role: STUDY_DIRECTOR
affiliation: Ain Shams University (Obs&Gyn)
name: Ahmed K Mekled, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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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.
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.
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.
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.
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.
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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