Uterine Lesions and Their Association to Invitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI) Outcome

June 26, 2021 updated by: Khaled Mostafa Ahmed, Assiut University

Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.

  1. To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
  2. To establish a score for prediction of IVF/ICSI cycle success .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

IVF is one of the most successful treatment of fertility, (1) however, several IVF cycles fail to achieve pregnancy (2).failure defined as three or more failed attempts of ICSI (3). Implantation failure is a complex in nature, may be due to structural or functional causes (3, 4).

that previously undiagnosed, misinterpreted initial diagnoses, or subtle newly added intrauterine abnormalities may be a significant cause of IVF failure (5, 6), studies say that intra-uterine pathologies represent 40-50 % of causes of ICSI failure (7, 8), hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum, or intrauterine adhesions could increase the pregnancy rate (9). so, Evaluation of the uterine cavity may become a routine investigation before assisted reproductive technology(ART) procedures (10).

In this study, we evaluate the relationship between the different uterine and cervical pathologies and decreased live birth rate.

Study Type

Observational

Enrollment (Anticipated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women between 18 and 38 years old.

  • An indication for IVF/ICSI..
  • Women with BMI between 18.5 : 29.9 .

Description

Inclusion Criteria:

  • Women between 18 and 38 years old.

    • An indication for IVF/ICSI..
    • Women with BMI between 18.5 : 29.9 .
    • Women with normal antimullerian hormone(AMH), antral follicle count(AFC) (good responders).

Exclusion Criteria:

Refusal to join the study.

  • Women with age less than 18 and more than 38 .
  • Women with BMI less than 18.5 and more than 30 .
  • Untreated tubal hydrosalpinges.
  • Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Women with hysteroscopically or ultrasonographic detected uterine anomalies(adenomyosis,fibroid) intracavitary lesions ( like polyp, adhesion or septum) and those with detected endometrial abnormalities (like hypervascularization,pale endometrium) ,cervical lesion and cervical canal lesion or pelvic lesion
Procedure: IVF
In vitro fertilization
Group B
Matched women (eg. Age,parity, BMI, ovarian reserve….) with no uterine or ovarian abnormalities assessed by hysteroscopy or ultrasonography.
Procedure: IVF
In vitro fertilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: Baseline
Pregnancy rate with IVF/ICSI with uterine lesions
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Momen Kamel, Prof.dr, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 26, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Uterine lesions and ICSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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