Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03680690
Collaborator
(none)
244
Enrollment
16.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: hysteroscopy

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
244 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Group A

women with normal uterus,detected by hysteroscopy.

Procedure: hysteroscopy
office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
Other Names:
  • hysteroscopic uterine lesion detection or correction

    		•
    Group B

    Women with detected or corrected uterine cavitary lesions by hysteroscopy.

    Procedure: hysteroscopy
    office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
    Other Names:
  • hysteroscopic uterine lesion detection or correction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [7th week of pregnancy for cardiac pulsations.]

      Clinical pregnancy rate Will be evaluated

    Secondary Outcome Measures

    1. Chemical pregnancy rate Chemical pregnancy rate [4 weeks]

      Chemical pregnancy rate Chemical pregnancy rate

    2. Implantation rate [6 weeks]

      Implantation rate for assessment of implanted embryos

    3. Abortion rate [up to 28 week]

      Abortion rate will be observed

    4. Preterm labour rate [9 months]

      Delivary before term 37 weeks of pregnancy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Ahmed Youssef, MD/MSC, women's health hospital,Assiut university
    • Study Director: Ibrahim Mohammed, MD/MSc, women's health hospital,Assiut university
    • Principal Investigator: Sayed Moustafa, MD/MSC, women's health hospital,Assiut university
    • Principal Investigator: Ahmed Kamel, MSC/MBBh, women's health hospital,Assiut university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Momen Ahmed Mohammed Kamel, Principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03680690
    Other Study ID Numbers:
    • pregnancy rate in ICSI cycles
    First Posted:
    Sep 21, 2018
    Last Update Posted:
    Sep 24, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 24, 2018