Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

Intracytoplasmic Sperm Injection Clinical Trial

Official title:

Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03680690
• Other study ID #: pregnancy rate in ICSI cycles
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Ahmed Kamel, MSc/Mbbh
• Phone: 00201003627020
• Email: ahmedmomen414[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 244
• Est. completion date: February 28, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intracytoplasmic Sperm Injection

Intervention

Procedure:
• hysteroscopy
office hysteroscopy will be done for all candidates and oprative correction of detected lesions will be carried on.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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/ — View 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. — View 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. — View 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-vitr — View 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. — View 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. Review. — View 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. — View Citation

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. Review. — View 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. Epu — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy rate Will be evaluated	7th week of pregnancy for cardiac pulsations.
Secondary	Chemical pregnancy rate Chemical pregnancy rate	Chemical pregnancy rate; Chemical pregnancy rate	4 weeks
Secondary	Implantation rate	Implantation rate for assessment of implanted embryos	6 weeks
Secondary	Abortion rate	Abortion rate will be observed	up to 28 week
Secondary	Preterm labour rate	Delevary before term 37 weeks of pregnancy	9 months