Trial | NCT01337531  Report issue

Title

Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    follitropin alfa ...

  • Study Participants

    200
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.
Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.
Study Started
May 31
2011
Primary Completion
Nov 30
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
Apr 19
2011
Estimate

Drug Gonal-F, Fostimon

dosage form

  • Other names: Recombinant Gonadotropin, Highly purified Gonadotropin

Drug Gonal-F, Fostimon

injection, daily, 10-15 days

  • Other names: Gonal-F, Fostimon

gonadotropin Experimental

recombinant or highly purified gonadotropin

Gonadotropins Active Comparator

recombinant versus highly purified gonadotropin

Criteria 

Inclusion Criteria:

PCOS
Primary infertility
No other fertility manifestation

Exclusion Criteria:

Non PCOS
Secondary infertility
No Results Posted