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

NCT ID: NCT02158000

Last Updated: 2022-06-28

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2021-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

group A

Intervention Type OTHER

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

Group B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Daflon

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

23 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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khalid abd aziz mohamed

lecturer of ob/gyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khalid mohamed

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology, Benha University Hospital

Locations

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Benha univesity hospital

Banhā, El Qualyobia, Egypt

Site Status

Countries

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Egypt

References

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Saad AS, Mohamed KAA. Aspiration with Diosmin Intake in Endometrial Cavity Fluid Accumulation in ART Cycles: A Randomized Controlled Trial. J Obstet Gynaecol India. 2023 Aug;73(4):336-342. doi: 10.1007/s13224-023-01791-7. Epub 2023 Aug 31.

Reference Type DERIVED
PMID: 37701088 (View on PubMed)

Other Identifiers

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khalid-ahmed 5

Identifier Type: -

Identifier Source: org_study_id

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