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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
February 8, 2010
February 9, 2010
July 21, 2011
January 2010
June 2011   (Final data collection date for primary outcome measure)
number of metaphase II oocytes [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01065376 on ClinicalTrials.gov Archive Site
  • embryo quality [ Time Frame: one year ]
  • pregnancy rate [ Time Frame: one year ]
  • The incidence of OHSS [ Time Frame: one year ]
embryo quality, pregnancy rate and the incidence of OHSS. [ Time Frame: one year ]
Not Provided
Not Provided
 
The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation
The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation in Women Undergoing Assisted Reproduction
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
In Vitro Fertilization
  • Procedure: the timing cabergoline administration
    received 0.5 mg oral cabergoline per day 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 after oocyte retrieval
  • Experimental: on the day of hCG
    cabergoline administration for 8 days on the day of hCG.
    Intervention: Procedure: the timing cabergoline administration
  • Experimental: on the day after oocyte retrieval
    cabergoline administration for 8 days on the day after oocyte retrieval
    Intervention: Procedure: the timing cabergoline administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

  • allergic to cabergoline
Sexes Eligible for Study: Female
20 Years to 38 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01065376
SKH-8302-99-DR-28
Yes
Not Provided
Not Provided
Jiann-Loung Hwang, Shin-Kong Wu Ho-Su Memorial Hospital
Shin Kong Wu Ho-Su Memorial Hospital
Not Provided
Study Chair: Jiann-Loung Hwang, MD Shin Kong Wu Ho-Su Memorial Hospital
Shin Kong Wu Ho-Su Memorial Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP