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

OHSS Clinical Trial

Official title:

Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02461875
• Other study ID #: Cabergoline / GnRH antagonist
• Status: Recruiting
• Phase: Phase 2
• First received: May 29, 2015
• Last updated: November 15, 2015
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Aljazeera Hospital
• Contact: Usama M Fouda, M.D,PhD
• Phone: 01095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• OHSS
• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Aljazeera( Al Gazeera) hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Aljazeera Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate or severe ovarian hyperstimulation syndrome		Within 4 weeks of HCG adminstration	Yes
Secondary	The Number of Participants Who Achieved Ongoing Pregnancy		18 weeks after embryo transfer	No