Trial | NCT01389713  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    289
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).
Study Started
Sep 30
2008
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Jul 12
2011
Estimate

Drug Clomifene Citrate

3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle

  • Other names: clomid

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.

  • Other names: decapeptyl, Gonal-F

High doses Active Comparator

Administration of high doses of gonadotrophins to stimulate ovarian follicular growth

Clomid Experimental

Administration of Clomiphene Citrate to obtain ovarian follicular growth

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
No Results Posted