Hum. Reprod. Advance Access originally published online on May 12, 2005
Human Reproduction 2005 20(7):1757-1771; doi:10.1093/humrep/deh818
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
MINI REVIEW: DEVELOPMENTS IN REPRODUCTIVE MEDICINE |
Resolving methodological and clinical issues in the design of efficacy trials in assisted reproductive technologies: a mini-review
1 Ferring Pharmaceuticals A/S, Clinical Research and Development, Copenhagen, 2 The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark and 3 McMaster University, Hamilton, Canada
4 To whom correspondence should be addressed at: 400 Mader's Cove Road RR1, Mahone Bay NS B3J 2E0, Canada. Email: collinsj{at}aura.com
The validity, importance and relevance of randomized controlled trials depend on identifying an appropriate target population, ensuring adequate power, careful attention to the details of randomization and blinding, and selection of an endpoint that is important to the target population. With efficacy trials more than effectiveness trials, additional constraints are needed to reduce the variability that is typical of clinical practice: a narrowly defined sample, unvarying pre-randomization procedures and post-randomization treatments and follow-up that are as identical as possible for all patients. Efficacy trials comparing ovarian stimulation protocols should have strict protocol definitions, specific concomitant medications and minimal variability between centres with respect to stimulation goals and dose adjustments. Additionally, there should be narrowly defined criteria for administration of chorionic gonadotrophin, type of luteal support, embryo transfer and freezing policies. The goal of efficacy trials is to minimize the variability that is extrinsic to the comparison. When efficacy has been proven, effectiveness trials are needed to determine whether the effect of the new intervention is robust in the variability of typical clinical settings.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  E. Manheimer, G. Zhang, L. Udoff, A. Haramati, P. Langenberg, B. M Berman, and L. M Bouter Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis BMJ, March 8, 2008; 336(7643): 545 - 549. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. M.H. Combelles What are the trade-offs between one-cell and two-cell biopsies of preimplantation embryos? Hum. Reprod., March 1, 2008; 23(3): 493 - 498. [Full Text] [PDF]
|
|
|
|
|
|
B. Ata, K. Yakin, B. Balaban, and B. Urman GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonistprotocol: a randomized, controlled double blind study Hum. Reprod., March 1, 2008; 23(3): 668 - 673. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. NyboeAndersen, P. Humaidan, G. Fried, J. Hausken, L. Antila, S. Bangsboll, P.E. Rasmussen, S. Lindenberg, H. E. Bredkjaer, H. Meinertz, et al. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial Hum. Reprod., February 1, 2008; 23(2): 427 - 434. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E.M. Kolibianakis, L. Kalogeropoulou, G. Griesinger, E.G. Papanikolaou, J. Papadimas, J. Bontis, and B.C. Tarlatzis Among patients treated with FSH and GnRH analogues for in vitro fertilization, is the addition of recombinant LH associated with the probability of live birth? A systematic review and meta-analysis Hum. Reprod. Update, September 1, 2007; 13(5): 445 - 452. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. A. Collins Preimplantation Genetic Screening in Older Mothers N. Engl. J. Med., July 5, 2007; 357(1): 61 - 63. [Full Text] [PDF]
|
|
|
|
|
|
A. N. Andersen, P. Devroey, and J.-C. Arce Reply: Comparing highly purified hMG and rFSH in patients undergoing IVF Hum. Reprod., June 1, 2007; 22(6): 1798 - 1800. [Full Text] [PDF]
|
|
|
|
|
|
J. Smitz, A.N. Andersen, P. Devroey, J.-C. Arce, and for the MERIT Group Endocrine profile in serum and follicular fluid differs after ovarian stimulation with HP-hMG or recombinant FSH in IVF patients Hum. Reprod., March 1, 2007; 22(3): 676 - 687. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. N. Andersen, P. Devroey, J.-C. Arce, and for the MERIT Group Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial Hum. Reprod., December 1, 2006; 21(12): 3217 - 3227. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E.M. Kolibianakis, J. Collins, B.C. Tarlatzis, P. Devroey, K. Diedrich, and G. Griesinger Among patients treated for IVF with gonadotrophins and GnRH analogues, is the probability of live birth dependent on the type of analogue used? A systematic review and meta-analysis Hum. Reprod. Update, November 1, 2006; 12(6): 651 - 671. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J.-C. Arce, S. Ziebe, K. Lundin, R. Janssens, L. Helmgaard, and P. Sorensen Interobserver agreement and intraobserver reproducibility of embryo quality assessments Hum. Reprod., August 1, 2006; 21(8): 2141 - 2148. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B.C. Tarlatzis, B.C. Fauser, E.M. Kolibianakis, K. Diedrich, P. Devroey, and , On Behalf of the Brussels GnRH Antagonist Consen GnRH antagonists in ovarian stimulation for IVF Hum. Reprod. Update, July 1, 2006; 12(4): 333 - 340. [Abstract] [Full Text] [PDF]
|
|