Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
NCT ID: NCT03680690
Last Updated: 2018-09-24
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
244 participants
OBSERVATIONAL
2018-10-01
2020-02-28
Brief Summary
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Detailed Description
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A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected.
However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted.
An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
women with normal uterus,detected by hysteroscopy.
hysteroscopy
office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
Group B
Women with detected or corrected uterine cavitary lesions by hysteroscopy.
hysteroscopy
office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
Interventions
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hysteroscopy
office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* An indication for IVF/ICSI.
* Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
* Women with primary or secondary infertility.
* Women with BMI between 20 \& 35.
Exclusion Criteria
* Untreated tubal hydrosalpinges.
* Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
18 Years
38 Years
FEMALE
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Momen Ahmed Mohammed Kamel
Principle investigator
Principal Investigators
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Ahmed Youssef, MD/MSC
Role: STUDY_CHAIR
women's health hospital,Assiut university
Ibrahim Mohammed, MD/MSc
Role: STUDY_DIRECTOR
women's health hospital,Assiut university
Sayed Moustafa, MD/MSC
Role: PRINCIPAL_INVESTIGATOR
women's health hospital,Assiut university
Ahmed Kamel, MSC/MBBh
Role: PRINCIPAL_INVESTIGATOR
women's health hospital,Assiut university
Central Contacts
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References
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Polanski LT, Baumgarten MN, Quenby S, Brosens J, Campbell BK, Raine-Fenning NJ. What exactly do we mean by 'recurrent implantation failure'? A systematic review and opinion. Reprod Biomed Online. 2014 Apr;28(4):409-23. doi: 10.1016/j.rbmo.2013.12.006. Epub 2014 Jan 17.
Coughlan C, Walters S, Ledger W, Li TC. A comparison of psychological stress among women with and without reproductive failure. Int J Gynaecol Obstet. 2014 Feb;124(2):143-7. doi: 10.1016/j.ijgo.2013.08.006. Epub 2013 Oct 31.
Zeyneloglu HB, Onalan G. Remedies for recurrent implantation failure. Semin Reprod Med. 2014 Jul;32(4):297-305. doi: 10.1055/s-0034-1375182. Epub 2014 Jun 11.
Papathanasiou A, Bhattacharya S. Prognostic factors for IVF success: diagnostic testing and evidence-based interventions. Semin Reprod Med. 2015 Mar;33(2):65-76. doi: 10.1055/s-0035-1545364. Epub 2015 Mar 3.
Moini A, Kiani K, Ghaffari F, Hosseini F. Hysteroscopic findings in patients with a history of two implantation failures following in vitro fertilization. Int J Fertil Steril. 2012 Apr;6(1):27-30. Epub 2012 Jun 19.
Cenksoy P, Ficicioglu C, Yildirim G, Yesiladali M. Hysteroscopic findings in women with recurrent IVF failures and the effect of correction of hysteroscopic findings on subsequent pregnancy rates. Arch Gynecol Obstet. 2013 Feb;287(2):357-60. doi: 10.1007/s00404-012-2627-5. Epub 2012 Nov 27.
Dicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2.
La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998 Aug;70(2):378-80. doi: 10.1016/s0015-0282(98)00147-2.
Levi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021.
El-Toukhy T, Campo R, Khalaf Y, Tabanelli C, Gianaroli L, Gordts SS, Gordts S, Mestdagh G, Mardesic T, Voboril J, Marchino GL, Benedetto C, Al-Shawaf T, Sabatini L, Seed PT, Gergolet M, Grimbizis G, Harb H, Coomarasamy A. Hysteroscopy in recurrent in-vitro fertilisation failure (TROPHY): a multicentre, randomised controlled trial. Lancet. 2016 Jun 25;387(10038):2614-2621. doi: 10.1016/S0140-6736(16)00258-0. Epub 2016 Apr 27.
Other Identifiers
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pregnancy rate in ICSI cycles
Identifier Type: -
Identifier Source: org_study_id
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