Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles

June 24, 2022 updated by: khalid abd aziz mohamed, Benha University
To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.

Study design: Prospective randomized controlled clinical trial.

Patients and Methods: 200 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are randomly scheduled into two equal groups. In group A, one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter ; while in group B (control group), no thing is given or done. The main outcome measures are presence of the fluid on the day of embryo transfer and the pregnancy rate on those patients.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
    • El Qualyobia
      • Banhā, El Qualyobia, Egypt, 13518
        • Benha Univesity Hospital

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

23 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles

Exclusion Criteria:

  • none

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
In group A , 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are allocated to receive one tab / 8 hs of Diosmin ( 500mg) beginning from the day of ovum retrieval and for 3 days (till the day of embro trasfer) in addition to aspiration of the fluid by an IUI catheter.
Other: group A
one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter
Other Names:
  • Daflon
No Intervention: Group B
In group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the pregnancy rate
Time Frame: is checked 16 days after embryos transfer
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)
is checked 16 days after embryos transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of the fluid on the day of embryo transfer
Time Frame: at the day of embryo transfer
detection of excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
at the day of embryo transfer

Collaborators and Investigators

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

Sponsor

Benha University

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 (Actual)

June 1, 2014

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • khalid-ahmed 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

on research gate

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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