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

Aljazeera Hospital236 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

236

Conditions

OHSS

Interventions

CabergolineDRUG

Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.

GnRH antagonist rescue & cabergolineDRUG

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

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Aljazeera( Al Gazeera) hospital

Giza, Giza Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

Moderate or severe ovarian hyperstimulation syndrome

Time frame: Within 4 weeks of HCG adminstration

Secondary Outcomes

The Number of Participants Who Achieved Ongoing Pregnancy

Time frame: 18 weeks after embryo transfer

Central Contacts

Usama M Fouda, M.D,PhD

CONTACT

01095401375 umfrfouda@yahoo.com

Data from ClinicalTrials.gov

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