Recombinant Versus Highly Purified FSH in Polycystic Ovar... | NCT01337531

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

NCT01337531

Sponsor

Genesis Center for Fertility & Human Pre-Implantation Genetics

Status

Unknown status

Last Update Posted

Apr 19, 2011Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Polycystic Ovary Syndrome

Interventions

Gonal-F, Fostimon
Gonal-F, Fostimon

Countries

Cyprus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Nov 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Apr 14, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2011

Last Update Posted Date

Apr 19, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Genesis Center for Fertility & Human Pre-Implantation GeneticsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gonadotropin	Experimental	recombinant or highly purified gonadotropin	Drug: Gonal-F, Fostimon
Gonadotropins	Active Comparator	recombinant versus highly purified gonadotropin	Drug: Gonal-F, Fostimon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gonal-F, Fostimon	Drug	dosage form	gonadotropin	Recombinant Gonadotropin, Highly purified Gonadotropin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovarian Response		0-15 days post gonadotropin administration

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate		12-15 days post embryo replacement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCOS
Primary infertility
No other fertility manifestation

Exclusion Criteria:

Non PCOS
Secondary infertility

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Savvas N Koundouros, PhD	Genesis Center for Fertility and Human Pre-implantation Genetics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Genesis Centre for Fertility and Human Pre-implantation Genetics		Limassol		3025	Cyprus

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C571801	follitropin alfa
D006062	Gonadotropins

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided