Abstract | BACKGROUND: METHODS: A randomized, double-blind, placebo-controlled, multicentre study assessing three oral doses (50, 100, 200 microg/day) of the non-ergot derived dopamine agonist quinagolide started on the day of human chorionic gonadotrophin (hCG) and continued for 17-21 days without dose-titration in comparison to placebo in preventing moderate/severe early OHSS (onset < or =9 days after hCG administration) in 182 IVF patients with > or =20 but less than 30 follicles > or =10 mm. RESULTS: The incidence of moderate/severe early OHSS was 23% (12/53) in the placebo group and 12% (6/51), 13% (7/52) and 4% (1/26) in the quinagolide 50, 100 and 200 microg/day groups, respectively. The moderate/severe early OHSS rate was significantly lower with all quinagolide groups combined compared with placebo [P = 0.019; OR = 0.28 (0.09-0.81)]. The incidence of ultrasound evidence of ascites among patients with no clinical pregnancy was significantly reduced from 31% (8/26) with placebo to 11% (8/70) with all quinagolide groups combined [P = 0.033; OR = 0.29 (0.10-0.88)], although there was no difference for those with clinical pregnancy. Quinagolide did not have a detrimental effect on pregnancy or live birth rates. The incidence of gastrointestinal and central nervous system adverse events increased with increasing doses of quinagolide. CONCLUSIONS:
Quinagolide appears to prevent moderate/severe early OHSS while not affecting treatment outcome. The effect is more marked in patients who did not achieve a clinical pregnancy. Quinagolide administered in high doses without dose-titration is associated with poor tolerability. ClinicalTrials.gov Identifier: NCT00329693.
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Authors | Cristiano Busso, Manuel Fernández-Sánchez, Juan Antonio García-Velasco, José Landeras, Augustín Ballesteros, Elkin Muñoz, Sandra González, Carlos Simón, Joan-Carles Arce, Antonio Pellicer |
Journal | Human reproduction (Oxford, England)
(Hum Reprod)
Vol. 25
Issue 4
Pg. 995-1004
(Apr 2010)
ISSN: 1460-2350 [Electronic] England |
PMID | 20139430
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aminoquinolines
- Dopamine Agonists
- quinagolide
- Prolactin
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Topics |
- Adult
- Aminoquinolines
(administration & dosage, adverse effects, pharmacology)
- Ascites
(prevention & control)
- Dopamine Agonists
(administration & dosage, adverse effects, pharmacology)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Fertilization in Vitro
(adverse effects)
- Humans
- Infant, Newborn
- Ovarian Hyperstimulation Syndrome
(blood, prevention & control)
- Pregnancy
- Pregnancy Outcome
- Prolactin
(blood)
- Sperm Injections, Intracytoplasmic
- Treatment Outcome
- Young Adult
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