Physical Endometrial Manipulation and Its Effect on ICSI

NCT ID: NCT03345251

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2017-12-28

Brief Summary

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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 .

Detailed Description

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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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

640 were enrolled but 608 were analyzed
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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manipulation of endometrium

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

Group Type EXPERIMENTAL

Hydrotubation

Intervention Type DEVICE

no manipulation to endometrium in ICSI

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

Group Type PLACEBO_COMPARATOR

Hydrotubation

Intervention Type DEVICE

Interventions

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Hydrotubation

Intervention Type DEVICE

Other Intervention Names

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Sonohysterography Endometrial scratching

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Alalfy

Mahmoud Alalfy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Alalfy, master

Role: STUDY_CHAIR

Algazeerah hospital -Location (Giza -Egypt )

Locations

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Algazeerah

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Algazeerah

Identifier Type: -

Identifier Source: org_study_id

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