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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01337531

Enrollment

200

Registered

2011-04-19

Start date

2011-05-31

Completion date

2011-12-31

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS

Brief summary

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

Detailed 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.

Interventions

DRUGGonal-F, Fostimon

dosage form

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* PCOS * Primary infertility * No other fertility manifestation

Exclusion criteria

* Non PCOS * Secondary infertility

Design outcomes

Primary

Measure	Time frame
Ovarian Response	0-15 days post gonadotropin administration

Secondary

Measure	Time frame
Pregnancy rate	12-15 days post embryo replacement

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026