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Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (infertility)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Diosmin
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, Diosmin, Cabergoline

Eligibility Criteria

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

Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following:

  1. Presence of more than 20 follicles by ultrasound
  2. E2 more than 3000 pg/ml
  3. Retrieval of more than 15 follicles

Exclusion Criteria:

  • none

Sites / Locations

  • Banha Universty
  • Benha univesity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (Diosmin group)

Group B(Cabergoline group)

Arm Description

In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.

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

Outcomes

Primary Outcome Measures

Number of participants with ovarian hyperstimulation syndrome (OHSS)
Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function).

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2014
Last Updated
January 29, 2016
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02134249
Brief Title
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Acronym
infertility
Official Title
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 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 Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Detailed Description
Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight 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, Diosmin, Cabergoline

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A (Diosmin group)
Arm Type
Active Comparator
Arm Description
In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.
Arm Title
Group B(Cabergoline group)
Arm Type
Active Comparator
Arm Description
while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be given at day of HCG injection and for 8 days .
Intervention Type
Drug
Intervention Name(s)
Diosmin
Other Intervention Name(s)
Daflon
Intervention Description
2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 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
Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function).
Time Frame
every week 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
23 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin 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 Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khalid mohamed, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, Benha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ahmed samy, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, Benha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha Universty
City
Banha
State/Province
El Qalubia
ZIP/Postal Code
13518
Country
Egypt
Facility Name
Benha univesity hospital
City
Benha
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
with other researcher on research gate
Citations:
PubMed Identifier
33851429
Citation
Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
Results Reference
derived

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Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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