Clinical trial NCT01065376: The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation
Official title: The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation in Women Undergoing Assisted Reproduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: In Vitro Fertilization
Keywords: IVF
OHSS
cabergoline
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* the risk of ovarian hyperstimulation syndrome development

Exclusion Criteria:

* allergic to cabergoline

Primary outcomes:
measure: number of metaphase II oocytes
timeFrame: one year
Secondary outcomes:
measure: embryo quality
timeFrame: one year
measure: pregnancy rate
timeFrame: one year
measure: The incidence of OHSS
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Jiann-Loung Hwang, MD
role: STUDY_CHAIR
References: