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Physical Endometrial Manipulation and Its Effect on ICSI

Sponsor
Aljazeera Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03345251
Collaborator
(none)
640
Enrollment
1
Location
2
Arms
11.8
Actual Duration (Months)
54.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Condition or Disease Intervention/Treatment Phase
  • Device: Hydrotubation
 N/A

Detailed Description

Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate

Study Design

Study Type:
Interventional
Actual Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
640 were enrolled but 608 were analyzed640 were enrolled but 608 were analyzed
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure
Actual Study Start Date :
Jan 3, 2017
Actual Primary Completion Date :
Dec 25, 2017
Actual Study Completion Date :
Dec 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: manipulation of endometrium

The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching

Device: Hydrotubation
Other Names:
  • Sonohysterography
  • Endometrial scratching

    		•
    Placebo Comparator: no manipulation to endometrium in ICSI

    This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group

    Device: Hydrotubation
    Other Names:
  • Sonohysterography
  • Endometrial scratching

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The number of participants who achieved clinical pregnancy [6 weeks after embryo transfer]

      Describes how many participant will continue pregnancy after positive pregnancy test

    Secondary Outcome Measures

    1. The number of participants who achieved ongoing pregnancy and live birth [9 months after embryo transfer]

      Describes who many participant will continue pregnancy till he had birth and a live birth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Infertile female age 20-35 years

    • Previous Failed one ICSI trial

    • normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity

    • patent tubes

    • normal Husband semen analysis

    Exclusion Criteria:

    • Ovarian factor of infertility

    • Tubal factor of infertility

    • Endometrial factor of infertility

    • Male factor of infertility

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Algazeerah Giza Egypt

    Sponsors and Collaborators

    • Aljazeera Hospital

    Investigators

    • Study Chair: Mahmoud Alalfy, master, Algazeerah hospital -Location (Giza -Egypt )

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Alalfy, Mahmoud Alalfy, Aljazeera Hospital
    ClinicalTrials.gov Identifier:
    NCT03345251
    Other Study ID Numbers:
    • Algazeerah
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahmoud Alalfy, Mahmoud Alalfy, Aljazeera Hospital
    ICSI - physical - Manipulation - scratching
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Sep 2, 2021