An Explorative Prospective Observational Study to Describ... | NCT02018159

Studies
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos

NCT02018159

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Aug 28, 2017Actual

Enrollment

738Actual

Phase

Not provided

Conditions

Infertility

Interventions

menotropin

Countries

Denmark

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 12, 2016Actual

Completion Date

May 12, 2016Actual

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 23, 2013Estimated

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

Aug 25, 2017

Last Update Posted Date

Aug 28, 2017Actual

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

This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

738Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women treated with Menopur		Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled.	Drug: menotropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
menotropin	Drug		Women treated with Menopur	Menopur

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells		1 week after oocyte retrieval
Incidence of uneven blastomeres at the 2 and 4 cell stage		1 week after oocyte retrieval
Incidence of bi- and multinucleation at 2 cell and 4 cell stage		1 week after oocyte retrieval
Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage		1 week after oocyte retrieval

Secondary Outcomes

Measure	Description	Time Frame
Positive serum human Chorion Gonadotrophin (hCG) rate		13-15 days after transfer
Implantation rate		5 weeks after transfer
Clinical pregnancy rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 21-45 years
In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
Receiving follicle stimulation with Menopur 600/1200 IU

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women seeking fertility treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)		Horsens			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008596	Menotropins

Ancestor Terms

ID	Term
D006065	Gonadotropins, Pituitary
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided