Clinical trial NCT03680690: Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
Official title: Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracytoplasmic Sperm Injection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all infertile females will be assesed in IVF unite of women's health Hospital and will be recruted according to the inclusion criteria

Brief summary: The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.

Detailed description: Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome.

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.

Eligibility criteria: Inclusion Criteria:

* Women between 18 and 38 years old.
* 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:

* Refusal to join the study.
* Untreated tubal hydrosalpinges.
* Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7th week of pregnancy for cardiac pulsations.
Secondary outcomes:
measure: Chemical pregnancy rate Chemical pregnancy rate
timeFrame: 4 weeks
measure: Implantation rate
timeFrame: 6 weeks
measure: Abortion rate
timeFrame: up to 28 week
measure: Preterm labour rate
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: women's health hospital,Assiut university
name: Ahmed Youssef, MD/MSC
role: STUDY_CHAIR
affiliation: women's health hospital,Assiut university
name: Ibrahim Mohammed, MD/MSc
role: STUDY_DIRECTOR
affiliation: women's health hospital,Assiut university
name: Sayed Moustafa, MD/MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: women's health hospital,Assiut university
name: Ahmed Kamel, MSC/MBBh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.