drugset / Trial / NCT01389713
Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve
Completed
289 enrolled
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IRCCS San Raffaele · collabIstituti Clinici Zucchi · collabIstituto Clinico Humanitas · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).
Timeline
- Start
- 2008-09
- Primary completion
- 2010-12
- Completion
- 2010-12
Publications
- Background Heijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC. A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial. Lancet. 2007 Mar 3;369(9563):743-749. doi: 10.1016/S0140-6736(07)60360-2.
- Background Eijkemans MJ, Heijnen EM, de Klerk C, Habbema JD, Fauser BC. Comparison of different treatment strategies in IVF with cumulative live birth over a given period of time as the primary end-point: methodological considerations on a randomized controlled non-inferiority trial. Hum Reprod. 2006 Feb;21(2):344-51. doi: 10.1093/humrep/dei332. Epub 2005 Oct 20.
- Ragni G, Levi-Setti PE, Fadini R, Brigante C, Scarduelli C, Alagna F, Arfuso V, Mignini-Renzini M, Candiani M, Paffoni A, Somigliana E. Clomiphene citrate versus high doses of gonadotropins for in vitro fertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial. Reprod Biol Endocrinol. 2012 Dec 18;10:114. doi: 10.1186/1477-7827-10-114.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clomiphene | Other / unclassified | 150 mg | — |
| Comparator | Decapeptyl | Unknown | 0.1 mg | Subcutaneous |
| Comparator | recombinant-human FSH | Protein / enzyme biologic | 450 iu | — |