Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
1 other identifier
interventional
200
1 country
1
Brief Summary
To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJune 28, 2022
June 1, 2022
7.4 years
June 5, 2014
June 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the pregnancy rate
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)
is checked 16 days after embryos transfer
Secondary Outcomes (1)
presence of the fluid on the day of embryo transfer
at the day of embryo transfer
Study Arms (2)
Group A
ACTIVE COMPARATORIn 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 B
NO INTERVENTIONIn group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done
Interventions
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
Eligibility Criteria
You may qualify if:
- women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha univesity hospital
Banhā, El Qualyobia, 13518, Egypt
Related Publications (1)
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.
PMID: 37701088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
khalid mohamed
Department of Obstetrics and Gynecology, Benha University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of ob/gyn
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 6, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
on research gate