Document Detail


Induction of final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment--recombinant HCG versus urinary HCG. The European Recombinant Human Chorionic Gonadotrophin Study Group.
MedLine Citation:
PMID:  10875887     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This multicentre, double-blind, double-dummy, randomized, parallel-group study compared the efficacy and safety of recombinant human chorionic gonadotrophin (rHCG) (Ovidrel((R))) and urinary HCG (uHCG) (Profasi((R))) for inducing final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment. Following long down-regulation and stimulation with recombinant human FSH (rFSH) (Gonal-F((R))), a total of 190 women received a single, s.c. injection of either 250 microg rHCG or 5000 IU uHCG. For evaluable patients (n = 172), the mean number of oocytes retrieved per patient (primary efficacy endpoint) was 11.6 for rHCG and 10.6 for uHCG (not significant). The mean number of mature oocytes was statistically higher (P = 0.027) for the rHCG group than the uHCG (9.4 versus 7.1). Serum progesterone concentrations on day 1 and days 6-7 post-HCG, and serum HCG concentrations at all post-HCG time points were statistically significantly in favour of rHCG. The clinical pregnancy rate was somewhat higher (not significant) in the rHCG group (33 versus 25%) as was the live birth rate (27 versus 23%, not significant). Both treatments were well tolerated, though the incidence of adverse events was significantly higher in the uHCG group (45.1 versus 22.7%, P = 0.0004). The incidence of injection-site reactions was significantly lower in the rHCG group (P = 0.0001). In conclusion, for triggering ovulation, rHCG seems to have significant advantages compared with uHCG in terms of number of mature oocytes retrieved, luteal progesterone and local tolerance.
Authors:
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Human reproduction (Oxford, England)     Volume:  15     ISSN:  0268-1161     ISO Abbreviation:  Hum. Reprod.     Publication Date:  2000 Jul 
Date Detail:
Created Date:  2000-09-08     Completed Date:  2000-09-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8701199     Medline TA:  Hum Reprod     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1446-51     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adult
Chorionic Gonadotropin / adverse effects,  blood,  therapeutic use*,  urine
Corpus Luteum / physiology*
Double-Blind Method
Embryo Implantation
Embryo Transfer
Female
Humans
Oocytes
Ovarian Follicle / physiology*
Ovulation Induction*
Pregnancy
Progesterone / blood
Recombinant Proteins / therapeutic use
Reproductive Techniques*
Specimen Handling
Sperm Injections, Intracytoplasmic
Chemical
Reg. No./Substance:
0/Chorionic Gonadotropin; 0/Ovidrel; 0/Profasi; 0/Recombinant Proteins; 57-83-0/Progesterone

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