Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve (clomid)
|Infertility||Drug: Clomifene Citrate Drug: GnRH analog and recombinant human FSH|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues|
- live birth rate [ Time Frame: end of the study (28 months) ]
general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment.
Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy.
- ratio pregnancies/costs [ Time Frame: end of the study (28 months) ]at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups.
|Study Start Date:||September 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: High doses
Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
Drug: GnRH analog and recombinant human FSH
daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
Administration of Clomiphene Citrate to obtain ovarian follicular growth
Drug: Clomifene Citrate
3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
Other Name: clomid
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389713
|Fondazione Ca' Granda Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||guido ragni, md||Fondazione Ca' Granda Ospedale Maggiore Policlinico|