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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02461875

Enrollment

236

Registered

2015-06-03

Start date

2013-05-31

Completion date

2015-12-31

Last updated

2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OHSS

Keywords

OHSS, Infertility, Cabergoline, GnRH antagonist, IVF-ET

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.

Interventions

DRUGCabergoline

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

DRUGGnRH 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
Moderate or severe ovarian hyperstimulation syndrome	Within 4 weeks of HCG adminstration

Secondary

Measure	Time frame
The Number of Participants Who Achieved Ongoing Pregnancy	18 weeks after embryo transfer

Countries

Egypt

Contacts

Primary ContactUsama M Fouda, M.D,PhD

umfrfouda@yahoo.com01095401375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026