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

NCT ID: NCT01337531

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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gonadotropin

recombinant or highly purified gonadotropin

Group Type EXPERIMENTAL

Gonal-F, Fostimon

Intervention Type DRUG

dosage form

Gonadotropins

recombinant versus highly purified gonadotropin

Group Type ACTIVE_COMPARATOR

Gonal-F, Fostimon

Intervention Type DRUG

injection, daily, 10-15 days

Interventions

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Gonal-F, Fostimon

dosage form

Intervention Type DRUG

Gonal-F, Fostimon

injection, daily, 10-15 days

Intervention Type DRUG

Other Intervention Names

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Recombinant Gonadotropin, Highly purified Gonadotropin Gonal-F Fostimon

Eligibility Criteria

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Inclusion Criteria

* PCOS
* Primary infertility
* No other fertility manifestation

Exclusion Criteria

* Non PCOS
* Secondary infertility
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Genesis Center for Fertility & Human Pre-Implantation Genetics

OTHER

Sponsor Role lead

Responsible Party

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Responsible party is an organization

Principal Investigators

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Savvas N Koundouros, PhD

Role: PRINCIPAL_INVESTIGATOR

Genesis Center for Fertility and Human Pre-implantation Genetics

Locations

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Genesis Centre for Fertility and Human Pre-implantation Genetics

Limassol, , Cyprus

Site Status

Countries

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Cyprus

Other Identifiers

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rFSH.- HP-FSH.PCOS

Identifier Type: -

Identifier Source: org_study_id

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