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

Information source: Aljazeera Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: OHSS

Intervention: Cabergoline (Drug); GnRH antagonist rescue & cabergoline (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Aljazeera Hospital

Official(s) and/or principal investigator(s):
Usama M Fouda, M.D,PhD, Study Chair, Affiliation: Aljazeera (Al Gazeera) hospital

Overall contact:
Usama M Fouda, M.D,PhD, Phone: 01095401375, Email: umfrfouda@yahoo.com

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.

Clinical Details

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

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

Primary outcome: Moderate or severe ovarian hyperstimulation syndrome

Secondary outcome: The Number of Participants Who Achieved Ongoing Pregnancy

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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 and Contacts

Usama M Fouda, M.D,PhD, Phone: 01095401375, Email: umfrfouda@yahoo.com

Aljazeera( Al Gazeera) hospital, Giza, Egypt; Recruiting
Usama M. Fouda, M.D , PhD, Phone: 01095401375, Ext: +2, Email: umfrfouda@yahoo.com
Usama M. Fouda, M.D , PhD, Principal Investigator
Additional Information

Related publications:

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.

Starting date: May 2012
Last updated: June 14, 2015

Page last updated: August 23, 2015

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