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The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

S

Shin Kong Wu Ho-Su Memorial Hospital

Status and phase

Completed
Phase 4

Conditions

In Vitro Fertilization

Treatments

Procedure: the timing cabergoline administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01065376
SKH-8302-99-DR-28

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

20 to 38 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • the risk of ovarian hyperstimulation syndrome development

Exclusion criteria

  • allergic to cabergoline

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

on the day of hCG
Experimental group
Description:
cabergoline administration for 8 days on the day of hCG.
Treatment:
Procedure: the timing cabergoline administration
Procedure: the timing cabergoline administration
on the day after oocyte retrieval
Experimental group
Description:
cabergoline administration for 8 days on the day after oocyte retrieval
Treatment:
Procedure: the timing cabergoline administration
Procedure: the timing cabergoline administration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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