CClinicalTrials.gg
Status unknownNCT03680690Updated Sep 24, 2018

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

An observational study in Intracytoplasmic Sperm Injection, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-24.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
244
Ages
18 Years to 38 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Intracytoplasmic Sperm Injection
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
244 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

    women with normal uterus,detected by hysteroscopy.

    Procedure: hysteroscopy

  • Group B

    Women with detected or corrected uterine cavitary lesions by hysteroscopy.

    Procedure: hysteroscopy

Interventions

  • Procedurehysteroscopy

    office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.

    Also known as: hysteroscopic uterine lesion detection or correction

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Clinical pregnancy rate Will be evaluated

    Time frame: 7th week of pregnancy for cardiac pulsations.

Secondary outcomes

  1. Chemical pregnancy rate Chemical pregnancy rate

    Chemical pregnancy rate Chemical pregnancy rate

    Time frame: 4 weeks

  2. Implantation rate

    Implantation rate for assessment of implanted embryos

    Time frame: 6 weeks

  3. Abortion rate

    Abortion rate will be observed

    Time frame: up to 28 week

  4. Preterm labour rate

    Delivary before term 37 weeks of pregnancy

    Time frame: 9 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24581986 ↗
  • 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. PubMed 24290538 ↗
  • 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. PubMed 24919029 ↗
  • 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. PubMed 25734344 ↗
  • 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. PubMed 25505508 ↗
  • 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. PubMed 23183783 ↗
  • 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. PubMed 1426335 ↗
  • 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. PubMed 9696242 ↗
  • 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. PubMed 15731311 ↗
  • 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. PubMed 27132053 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03680690
Lead sponsor
Assiut University
Responsible party
Ahmed Momen Ahmed Mohammed Kamel (Principle investigator, Assiut University) — Principal investigator
First posted
Sep 21, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Dec 30, 2019 (estimated)
Completion
Feb 28, 2020 (estimated)
Last update
Sep 24, 2018

Study contacts

Ahmed Kamel, MSc/Mbbh
Contact
ahmedmomen414@yahoo.com
00201003627020
Ahmed Youssef, MD/Mssc/Mbbh
Contact
ahmedalaa11828@yahoo.com
01006184921
Ahmed Youssef, MD/MSC
study chair · women's health hospital,Assiut university
Ibrahim Mohammed, MD/MSc
study director · women's health hospital,Assiut university
Sayed Moustafa, MD/MSC
principal investigator · women's health hospital,Assiut university
Ahmed Kamel, MSC/MBBh
principal investigator · women's health hospital,Assiut university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion