Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
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
November 8, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 14, 2017
February 1, 2017
2.5 years
November 8, 2014
February 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with ovarian hyperstimulation syndrome (OHSS)
this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia
every two weeks for eight weeks
Secondary Outcomes (1)
pregnancy rate
14 days after embryos transfer
Study Arms (2)
group A
ACTIVE COMPARATORIn group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.
group B
ACTIVE COMPARATORIn group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
Interventions
1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
Eligibility Criteria
You may qualify if:
- Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:
- Presence of more than 20 follicles by ultrasound
- E2 more than 3000 pg/ml
- Retrieval of more than 15 follicles
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benha univesity hospital
Banhā, 13518, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ahmed saad, MD
lecturer of ob/gyn
- STUDY DIRECTOR
khalid mohamed, MD
lecturer of ob/gyn
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer of ob/gyn
Study Record Dates
First Submitted
November 8, 2014
First Posted
November 13, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 14, 2017
Record last verified: 2017-02