Aneuploidy Rate and Stimulation Protocol: Recombinant Fol... | NCT01164943

Studies
Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

NCT01164943

Sponsor

IVI Madrid

Status

Terminated

Last Update Posted

Feb 25, 2016Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Aneuploidy Rate

Interventions

Stimulation with human FSH
Stimulation with recombinant FSH

Countries

Spain

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 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 16, 2010

First Submission Date that Met QC Criteria

Jul 16, 2010

First Posted Date

Jul 19, 2010Estimated

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

Feb 24, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human FSH	Active Comparator		Procedure: Stimulation with human FSH
Recombinant FSH	Active Comparator		Procedure: Stimulation with recombinant FSH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulation with human FSH	Procedure	Human FSH	Human FSH
Stimulation with recombinant FSH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aneuploidy Rate	Analysis of all nuclei fixed	2011 January

Secondary Outcomes

Measure	Description	Time Frame
Oocyte morphology	Analysis of all oocytes	2011 january
Outcome rates (implantation, pregnancy and miscarriage rate)	Time requierd to know all the implantation, pregnancy and miscarriage rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria:

Male factor
Uterine malformations
genetic alterations

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Insituto Valenciano de Infertilida, Spain, Madrid		Madrid	Madrid	28023	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D043373	Follicle Stimulating Hormone, Human

Ancestor Terms

ID	Term
D005640	Follicle Stimulating Hormone
D006065	Gonadotropins, Pituitary
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided