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Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome

Primary Purpose

OHSS

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cabergoline
GnRH antagonist rescue & cabergoline
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OHSS focused on measuring OHSS, Infertility, Cabergoline, GnRH antagonist, IVF-ET

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol and at high risk of developing OHSS [ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml]

Exclusion Criteria:

  • Fibrosis of lung,
  • swelling or inflammation around the heart or lung,
  • hypertension,
  • liver disease,
  • heart valve disease and
  • allergy to cabergoline or ergot derivatives.

Sites / Locations

  • Aljazeera( Al Gazeera) hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cabergoline group

GnRH antagonist rescue & cabergoline group

Arm Description

Cabergoline is administered starting on the day of HCG administration.

Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration.

Outcomes

Primary Outcome Measures

Moderate or severe ovarian hyperstimulation syndrome

Secondary Outcome Measures

The Number of Participants Who Achieved Ongoing Pregnancy

Full Information

First Posted
May 29, 2015
Last Updated
November 15, 2015
Sponsor
Aljazeera Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02461875
Brief Title
Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome
Official Title
Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.
Detailed Description
Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of assisted reproduction. Complications of OHSS include vascular thrombosis, pulmonary embolism, renal failure, electrolyte disturbances, ascites, hydrothorax ,torsion of the ovary, abortion or rarely death. Previous studies revealed that converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS. The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OHSS
Keywords
OHSS, Infertility, Cabergoline, GnRH antagonist, IVF-ET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cabergoline group
Arm Type
Active Comparator
Arm Description
Cabergoline is administered starting on the day of HCG administration.
Arm Title
GnRH antagonist rescue & cabergoline group
Arm Type
Experimental
Arm Description
Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Intervention Description
Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist rescue & cabergoline
Intervention Description
when the leading follicle reaches 16 mm, HP-uFSH is continued at daily dose of 75 IU/day till the day of HCG administration. Moreover, Gn RH agonist (triptorelin) is discontinued and GnRH antagonist (Cetrorelix acetate)0.25 mg S.C is administered daily till the day of HCG administration. Serum estradiol is measured daily and HCG (5,000 IU/I.M) is administered when serum estradiol level drops below 3500 pg/ml . Moreover, cabergoline 0.5 mg p.o is administered at bed time for 8 days starting on the day of HCG administration.
Primary Outcome Measure Information:
Title
Moderate or severe ovarian hyperstimulation syndrome
Time Frame
Within 4 weeks of HCG adminstration
Secondary Outcome Measure Information:
Title
The Number of Participants Who Achieved Ongoing Pregnancy
Time Frame
18 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol and at high risk of developing OHSS [ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml] Exclusion Criteria: Fibrosis of lung, swelling or inflammation around the heart or lung, hypertension, liver disease, heart valve disease and allergy to cabergoline or ergot derivatives.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usama M Fouda, M.D,PhD
Phone
01095401375
Email
umfrfouda@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, M.D,PhD
Organizational Affiliation
Aljazeera (Al Gazeera) hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama M. Fouda, M.D, PhD
Phone
01095401375
Ext
+2
Email
umfrfouda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Usama M. Fouda, M.D, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17854523
Citation
Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9. doi: 10.1016/s1472-6483(10)60339-2.
Results Reference
background
PubMed Identifier
27184139
Citation
Fouda UM, Sayed AM, Elshaer HS, Hammad BE, Shaban MM, Elsetohy KA, Youssef MA. GnRH antagonist rescue protocol combined with cabergoline versus cabergoline alone in the prevention of ovarian hyperstimulation syndrome: a randomized controlled trial. J Ovarian Res. 2016 May 17;9(1):29. doi: 10.1186/s13048-016-0237-8.
Results Reference
derived

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Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome

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