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Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Calcium Dobesilate
Cabergoline
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility focused on measuring infertility ICSI OHSS Calcium Dobesilate Cabergoline

Eligibility Criteria

22 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., > 24 antral follicles present on baseline ultrasound examination), high AMH (> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 >3000 pg/ml or rapidly rising s.E2), presence of > 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (> 20).

Exclusion Criteria:

  • None

Sites / Locations

  • Benha univesity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

In 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.

while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be givenat day of HCG injection and for 8 days .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pregnancy rate
β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Full Information

First Posted
October 19, 2014
Last Updated
February 14, 2017
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02271360
Brief Title
Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Official Title
Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (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
The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Detailed Description
Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility ICSI OHSS Calcium Dobesilate Cabergoline

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
In 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.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be givenat day of HCG injection and for 8 days .
Intervention Type
Drug
Intervention Name(s)
Calcium Dobesilate
Other Intervention Name(s)
doxium
Intervention Description
1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Dostinex
Intervention Description
1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Primary Outcome Measure Information:
Title
Number of participants with ovarian hyperstimulation syndrome (OHSS)
Description
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
Time Frame
weekly for eight weeks
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
β-hCG (serum hCG test) will be checked 14 days after embryos transfer
Time Frame
14 days after embryos transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., > 24 antral follicles present on baseline ultrasound examination), high AMH (> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 >3000 pg/ml or rapidly rising s.E2), presence of > 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (> 20). Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid mohamed, MD
Organizational Affiliation
lecturer of ob/gyn
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ahmed saad, MD
Organizational Affiliation
lecturer of ob/gyn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha univesity hospital
City
Benha
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

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Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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