Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)

Genesis Center for Fertility & Human Pre-Implantation Genetics

Status and phase: Unknown; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Gonal-F, Fostimon

Study type: Interventional

Funder types: Other

Identifiers

NCT01337531

rFSH.- HP-FSH.PCOS

Details and patient eligibility

About

Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.

Full description

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PCOS
• Primary infertility
• No other fertility manifestation

Exclusion criteria

• Non PCOS
• Secondary infertility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups

gonadotropin

Experimental group

Description:

recombinant or highly purified gonadotropin

Treatment:

Drug: Gonal-F, Fostimon

Drug: Gonal-F, Fostimon

Gonadotropins

Active Comparator group

Description:

recombinant versus highly purified gonadotropin

Treatment:

Drug: Gonal-F, Fostimon

Drug: Gonal-F, Fostimon