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The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065376
First Posted: February 9, 2010
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shin Kong Wu Ho-Su Memorial Hospital
  Purpose
The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF) overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis.This study was designed to analyze whether the timing cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

Condition Intervention Phase
In Vitro Fertilization Procedure: the timing cabergoline administration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation in Women Undergoing Assisted Reproduction

Resource links provided by NLM:


Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • number of metaphase II oocytes [ Time Frame: one year ]

Secondary Outcome Measures:
  • embryo quality [ Time Frame: one year ]
  • pregnancy rate [ Time Frame: one year ]
  • The incidence of OHSS [ Time Frame: one year ]

Estimated Enrollment: 120
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: on the day of hCG
cabergoline administration for 8 days on the day of hCG.
Procedure: the timing cabergoline administration
received 0.5 mg oral cabergoline per day for 8 days on the day of hCG
Experimental: on the day after oocyte retrieval
cabergoline administration for 8 days on the day after oocyte retrieval
Procedure: the timing cabergoline administration
received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval

Detailed Description:

BACKGROUND:Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction. It results from increased vascular permeability caused by ovarian hypersecretion of VEGF), which activates its receptor-2. The dopamine agonist cabergoline inhibits phosphorylation of the receptor VEGFR-2, which prevent VEGF overexpression and reduce the severity of OHSS. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis. In human, cabergoline averts OHSS, but a possible detrimental effect on oocyte maturation has not been explored. This study was designed to analyze whether the timing cabergoline administration on the day of hCG injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

PURPOSE: To assess whether the timing cabergoline administration affects metaphase II oocytes numbers, embryo quality, pregnancy outcome and the incidence of OHSS.

METHODS: A prospective randomized study was designed to evaluate the possible of cabergoline affect on oocyte maturation. Women (n=120) under controlled ovarian hyperstimulation with the risk of OHSS (Estradiol(E2)>4000 pg/ml, or >18 follicle, >11 mm development) randomized into two groups. Group I (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day of hCG. Group II (n=60) received 0.5 mg oral cabergoline per day for 8 days on the day after oocyte retrieval immediately.

ANTICIPATED RESULTS: No significant differences were seen in the number of metaphase II oocytes, the embryo quality, the pregnancy rate and the incidence of OHSS.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

  • allergic to cabergoline
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065376


Locations
Taiwan
Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Study Chair: Jiann-Loung Hwang, MD Shin Kong Wu Ho-Su Memorial Hospital
  More Information

Responsible Party: Jiann-Loung Hwang, Shin-Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01065376     History of Changes
Other Study ID Numbers: SKH-8302-99-DR-28
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: July 21, 2011
Last Verified: April 2011

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
IVF
OHSS
cabergoline

Additional relevant MeSH terms:
Dopamine
Cabergoline
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents