Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome
NCT ID: NCT02461875
Last Updated: 2015-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
236 participants
INTERVENTIONAL
2013-05-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cabergoline group
Cabergoline is administered starting on the day of HCG administration.
Cabergoline
Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.
GnRH antagonist rescue & cabergoline group
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.
GnRH antagonist rescue & cabergoline
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.
Interventions
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Cabergoline
Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.
GnRH antagonist rescue & cabergoline
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* swelling or inflammation around the heart or lung,
* hypertension,
* liver disease,
* heart valve disease and
* allergy to cabergoline or ergot derivatives.
18 Years
40 Years
FEMALE
No
Sponsors
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Aljazeera Hospital
OTHER
Responsible Party
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Prof .Usama M.Fouda
M.D , PhD
Principal Investigators
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Usama M Fouda, M.D,PhD
Role: STUDY_CHAIR
Aljazeera (Al Gazeera) hospital
Locations
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Aljazeera( Al Gazeera) hospital
Giza, Giza Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Cabergoline / GnRH antagonist
Identifier Type: -
Identifier Source: org_study_id