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The addition of GnRH antagonists in intrauterine insemination cycles with mild ovarian hyperstimulation does not increase live birth rates-a randomized, double-blinded, placebo-controlled trial

AEP Cantineau, BJ Cohlen, H Klip, MJ Heineman, the Dutch IUI Study group collaborators, Cornelis Lambalk UGent, Petra De Sutter UGent and Willem Ombelet UGent (2011) HUMAN REPRODUCTION. 26(5). p.1104-1111
abstract
BACKGROUND: This multicenter, double-blinded RCT investigated the efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation (MOH) followed by IUI in subfertile women. METHODS: Couples diagnosed with unexplained, male factor subfertility or associated with the presence of minimal or mild endometriosis were randomized with a computer-generated list of numbers by a third party in a double-blinded setting to receive either a GnRH antagonists or a placebo in 12 institutional or academic hospitals. All women were treated with recombinant FSH in a low-dose step-up regimen starting on Day 2-4 of the cycle. A GnRH antagonist was added when one or more follicles of 14 mm diameter or more were visualized. When at least one follicle reached a size of >= 18 mm, ovulation was induced by hCG injection. A single IUI was performed 38-40 h later. Couples were offered a maximum of three consecutive cycles. The primary outcome of the trial was live births. Secondary outcomes were pregnancy rates, multiple pregnancy rates, miscarriages and ovarian hyperstimulation syndrome rate. RESULTS: A total of 233 couples were included from January 2006 to February 2009, starting 572 treatment cycles. Live birth rates were not significantly different between the group treated with GnRH antagonist (8.4%; 23/275) and the placebo group (12%; 36/297) (P = 0.30). Three twin pregnancies occurred in the GnRH antagonist group and two twin pregnancies in the placebo group. CONCLUSIONS: Adding a GnRH antagonist in cycles with MOH in an IUI program does not increase live birth rates. Dutch Trial Register no: NTR497.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
FSH, MULTICENTER, SUBFERTILITY, intrauterine insemination, SURGE, GANIRELIX, COMBINATION, RCT, infertility, GnRH antagonist, GnRH agonist, PREGNANCY RATES, STIMULATED CYCLES
journal title
HUMAN REPRODUCTION
Hum. Reprod.
volume
26
issue
5
pages
1104 - 1111
Web of Science type
Article
Web of Science id
000289834200018
JCR category
OBSTETRICS & GYNECOLOGY
JCR impact factor
4.475 (2011)
JCR rank
3/78 (2011)
JCR quartile
1 (2011)
ISSN
0268-1161
DOI
10.1093/humrep/der033
language
English
UGent publication?
no
classification
A1
copyright statement
I have retained and own the full copyright for this publication
id
1850645
handle
http://hdl.handle.net/1854/LU-1850645
date created
2011-07-01 09:37:30
date last changed
2012-08-07 09:47:41
@article{1850645,
  abstract     = {BACKGROUND: This multicenter, double-blinded RCT investigated the efficacy of GnRH antagonists in cycles with mild ovarian hyperstimulation (MOH) followed by IUI in subfertile women. METHODS: Couples diagnosed with unexplained, male factor subfertility or associated with the presence of minimal or mild endometriosis were randomized with a computer-generated list of numbers by a third party in a double-blinded setting to receive either a GnRH antagonists or a placebo in 12 institutional or academic hospitals. All women were treated with recombinant FSH in a low-dose step-up regimen starting on Day 2-4 of the cycle. A GnRH antagonist was added when one or more follicles of 14 mm diameter or more were visualized. When at least one follicle reached a size of {\textrangle}= 18 mm, ovulation was induced by hCG injection. A single IUI was performed 38-40 h later. Couples were offered a maximum of three consecutive cycles. The primary outcome of the trial was live births. Secondary outcomes were pregnancy rates, multiple pregnancy rates, miscarriages and ovarian hyperstimulation syndrome rate. RESULTS: A total of 233 couples were included from January 2006 to February 2009, starting 572 treatment cycles. Live birth rates were not significantly different between the group treated with GnRH antagonist (8.4\%; 23/275) and the placebo group (12\%; 36/297) (P = 0.30). Three twin pregnancies occurred in the GnRH antagonist group and two twin pregnancies in the placebo group. 
CONCLUSIONS: Adding a GnRH antagonist in cycles with MOH in an IUI program does not increase live birth rates. Dutch Trial Register no: NTR497.},
  author       = {Cantineau, AEP and Cohlen, BJ and Klip, H and Heineman, MJ and Dutch IUI Study group collaborators, the and Lambalk, Cornelis and De Sutter, Petra and Ombelet, Willem},
  issn         = {0268-1161},
  journal      = {HUMAN REPRODUCTION},
  keyword      = {FSH,MULTICENTER,SUBFERTILITY,intrauterine insemination,SURGE,GANIRELIX,COMBINATION,RCT,infertility,GnRH antagonist,GnRH agonist,PREGNANCY RATES,STIMULATED CYCLES},
  language     = {eng},
  number       = {5},
  pages        = {1104--1111},
  title        = {The addition of GnRH antagonists in intrauterine insemination cycles with mild ovarian hyperstimulation does not increase live birth rates-a randomized, double-blinded, placebo-controlled trial},
  url          = {http://dx.doi.org/10.1093/humrep/der033},
  volume       = {26},
  year         = {2011},
}

Chicago
Cantineau, AEP, BJ Cohlen, H Klip, MJ Heineman, the Dutch IUI Study group collaborators, Cornelis Lambalk, Petra De Sutter, and Willem Ombelet. 2011. “The Addition of GnRH Antagonists in Intrauterine Insemination Cycles with Mild Ovarian Hyperstimulation Does Not Increase Live Birth Rates-a Randomized, Double-blinded, Placebo-controlled Trial.” Human Reproduction 26 (5): 1104–1111.
APA
Cantineau, A., Cohlen, B., Klip, H., Heineman, M., Dutch IUI Study group collaborators, the, Lambalk, C., De Sutter, P., et al. (2011). The addition of GnRH antagonists in intrauterine insemination cycles with mild ovarian hyperstimulation does not increase live birth rates-a randomized, double-blinded, placebo-controlled trial. HUMAN REPRODUCTION, 26(5), 1104–1111.
Vancouver
1.
Cantineau A, Cohlen B, Klip H, Heineman M, Dutch IUI Study group collaborators the, Lambalk C, et al. The addition of GnRH antagonists in intrauterine insemination cycles with mild ovarian hyperstimulation does not increase live birth rates-a randomized, double-blinded, placebo-controlled trial. HUMAN REPRODUCTION. 2011;26(5):1104–11.
MLA
Cantineau, AEP, BJ Cohlen, H Klip, et al. “The Addition of GnRH Antagonists in Intrauterine Insemination Cycles with Mild Ovarian Hyperstimulation Does Not Increase Live Birth Rates-a Randomized, Double-blinded, Placebo-controlled Trial.” HUMAN REPRODUCTION 26.5 (2011): 1104–1111. Print.