NCT03680690

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

September 17, 2018

Last Update Submit

September 20, 2018

Conditions

Intracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy rate Will be evaluated

    7th week of pregnancy for cardiac pulsations.

Secondary Outcomes (4)

  • Chemical pregnancy rate Chemical pregnancy rate

    4 weeks

  • Implantation rate

    6 weeks

  • Abortion rate

    up to 28 week

  • Preterm labour rate

    9 months

Study Arms (2)

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

hysteroscopyPROCEDURE

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
Group AGroup B

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile females
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 24581986RESULT

  • 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.

    PMID: 24290538RESULT

  • 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.

    PMID: 24919029RESULT

  • 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.

    PMID: 25734344RESULT

  • 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.

    PMID: 25505508RESULT

  • 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.

    PMID: 23183783RESULT

  • 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.

    PMID: 1426335RESULT

  • 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.

    PMID: 9696242RESULT

  • 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.

    PMID: 15731311RESULT

  • 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.

    PMID: 27132053RESULT

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Ahmed Youssef, MD/MSC

    women's health hospital,Assiut university

    STUDY CHAIR

  • Ibrahim Mohammed, MD/MSc

    women's health hospital,Assiut university

    STUDY DIRECTOR

  • Sayed Moustafa, MD/MSC

    women's health hospital,Assiut university

    PRINCIPAL INVESTIGATOR

  • Ahmed Kamel, MSC/MBBh

    women's health hospital,Assiut university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Kamel, MSc/Mbbh

CONTACT

00201003627020ahmedmomen414@yahoo.com

Ahmed Youssef, MD/Mssc/Mbbh

CONTACT

01006184921ahmedalaa11828@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 21, 2018

Study Start

October 1, 2018

Primary Completion

December 30, 2019

Study Completion

February 28, 2020

Last Updated

September 24, 2018

Record last verified: 2018-09