Embryo Kinetics and Stimulation Protocol: Recombinant Fol... | NCT01678651

Studies
Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

NCT01678651

Sponsor

IVI Madrid

Status

Terminated

Last Update Posted

Feb 24, 2016Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Embryo Kinetics

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

Mar 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

Aug 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Aug 31, 2012

First Submission Date that Met QC Criteria

Aug 31, 2012

First Posted Date

Sep 5, 2012Estimated

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 23, 2016

Last Update Posted Date

Feb 24, 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

Different kinetics markers have been proposed to select embryos with higher implantation rates. The effect of external factors on these markers, such as the stimulation protocol should be analyzed. There are two different types of FSH that are commonly used for in vitro fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if there is a difference in embryo kinetics and morphology as well as oocyte morphological parameters between the two types of FSH and therefore to analyze if such markers can be used despite of the stimulation protocols chosen.

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	Human FSH	Procedure: Stimulation with human FSH
Recombinant FSH	Active Comparator	Recombinant FSH	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
time of cell cleavage	Analysis of cell cleavage	February 2012

Secondary Outcomes

Measure	Description	Time Frame
Embryo and oocyte morphology	Analysis of all oocytes	February 2012
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		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