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

Phase 2

• Conditions: OHSS
• Interventions: Drug: GnRH antagonist rescue & cabergoline; Drug: Cabergoline

• Registration Number: NCT02461875
• Lead Sponsor: Aljazeera Hospital

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-15
• Last Update Posted: 2015-11-17
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 236

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist rescue & cabergoline group	GnRH antagonist rescue & cabergoline	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.
Cabergoline group	Cabergoline	Cabergoline is administered starting on the day of HCG administration.

Primary Outcome Measures

Name	Time	Method
Moderate or severe ovarian hyperstimulation syndrome	Within 4 weeks of HCG adminstration

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Ongoing Pregnancy	18 weeks after embryo transfer

Trial Locations

Locations (1)

Aljazeera( Al Gazeera) hospital; 🇪🇬 Giza, Egypt