NCT01389713

Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Clomifene Citrate	3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-07-08
• Last updated: 2011-07-12

Locations

1 site across 1 country: Italy