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

Genesis Center for Fertility & Human Pre-Implantation Genetics200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Polycystic Ovary Syndrome

Interventions

Gonal-F, FostimonDRUG

dosage form

Gonal-F, FostimonDRUG

injection, daily, 10-15 days

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * PCOS * Primary infertility * No other fertility manifestation Exclusion Criteria: * Non PCOS * Secondary infertility

Locations (1)

Genesis Centre for Fertility and Human Pre-implantation Genetics

Limassol, Cyprus

Outcomes

Primary Outcomes

Ovarian Response

Time frame: 0-15 days post gonadotropin administration

Secondary Outcomes

Pregnancy rate

Time frame: 12-15 days post embryo replacement

Data from ClinicalTrials.gov

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