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
Overview
- Phase
- Not Applicable
- Intervention
- GnRH analog and recombinant human FSH
- Conditions
- Infertility
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Enrollment
- 289
- Locations
- 1
- Primary Endpoint
- live birth rate
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 18-42 years
- •infertility status
- •Day 3 serum FSH \> 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation
Exclusion Criteria
- •contraindications to infertility treatments or pregnancy
Arms & Interventions
High doses
Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
Intervention: GnRH analog and recombinant human FSH
Clomid
Administration of Clomiphene Citrate to obtain ovarian follicular growth
Intervention: Clomifene Citrate
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- ratio pregnancies/costs(end of the study (28 months))