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

September 20, 2018 updated by: Ahmed Momen Ahmed Mohammed Kamel, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

244

Contacts and Locations

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

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

all infertile females will be assesed in IVF unite of women's health Hospital and will be recruted according to the inclusion criteria

Description

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).

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 7th week of pregnancy for cardiac pulsations.
Clinical pregnancy rate Will be evaluated
7th week of pregnancy for cardiac pulsations.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical pregnancy rate Chemical pregnancy rate
Time Frame: 4 weeks

Chemical pregnancy rate

Chemical pregnancy rate
4 weeks
Implantation rate
Time Frame: 6 weeks
Implantation rate for assessment of implanted embryos
6 weeks
Abortion rate
Time Frame: up to 28 week
Abortion rate will be observed
up to 28 week
Preterm labour rate
Time Frame: 9 months
Delivary before term 37 weeks of pregnancy
9 months

Collaborators and Investigators

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

Sponsor

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

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)

October 1, 2018

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • pregnancy rate in ICSI cycles

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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