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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
group A
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

23 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Benha univesity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A

Group B

Arm Description

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.

In group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done

Outcomes

Primary Outcome Measures

the pregnancy rate
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)

Secondary Outcome Measures

presence of the fluid on the day of embryo transfer
detection of excessive endometrial fluid by transvaginal ultrasound during ICSI cycles

Full Information

First Posted
June 5, 2014
Last Updated
June 24, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02158000
Brief Title
Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
Official Title
Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
November 2021 (Actual)
Study Completion Date
November 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
In group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done
Intervention Type
Other
Intervention Name(s)
group A
Other Intervention Name(s)
Daflon
Intervention Description
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
Primary Outcome Measure Information:
Title
the pregnancy rate
Description
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)
Time Frame
is checked 16 days after embryos transfer
Secondary Outcome Measure Information:
Title
presence of the fluid on the day of embryo transfer
Description
detection of excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
Time Frame
at the day of embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid mohamed
Organizational Affiliation
Department of Obstetrics and Gynecology, Benha University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Benha univesity hospital
City
Banhā
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
on research gate

Learn more about this trial

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

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