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

Aljazeera Hospital

Status and phase: Unknown; Phase 2

Conditions: OHSS

Treatments: Drug: Cabergoline; Drug: GnRH antagonist rescue & cabergoline

Study type: Interventional

Funder types: Other

Identifiers

NCT02461875

Cabergoline / GnRH antagonist

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Cabergoline group

Active Comparator group

Description:

Cabergoline is administered starting on the day of HCG administration.

Treatment:

Drug: Cabergoline

GnRH antagonist rescue & cabergoline group

Experimental group

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.

Treatment:

Drug: GnRH antagonist rescue & cabergoline