Study of the Cleavage of the Egg in Relation to the Stimu... | NCT01674894

Studies
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment

NCT01674894

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Aug 28, 2017Actual

Enrollment

356Actual

Phase

Not provided

Conditions

Female Infertility

Interventions

Not provided

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 2013

Primary Completion Date

Dec 10, 2015Actual

Completion Date

Mar 10, 2016Actual

First Submitted Date

Aug 21, 2012

First Submission Date that Met QC Criteria

Aug 27, 2012

First Posted Date

Aug 29, 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

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, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.

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

Not provided

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

356Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Women treated with Menopur
Group 2		Women treated with Menopur and Bravelle

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)		Week 1 after oocyte retrieval
Time for disappearance of pronuclei in transferred embryos		Week 1 after oocyte retrieval
Time for first cleavage in transferred embryos		Week 1 after oocyte retrieval
Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos		Week 1 after oocyte retrieval
Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage		Week 1 after oocyte retrieval

Secondary Outcomes

Measure	Description	Time Frame
Total dose of gonadotrophin used		1 month
Gonadotrophin dose per oocyte retrieved		1 month
Number of oocytes retrieved

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IVF/ICSI treatment
Regular cycles of 25-35 days
Follicle stimulation with Bravelle and/or Menopur
Women aged 38-35 years
Long agonist or short antagonist treatment
Willing and able to understand a Danish, English or German patient information form
Willing and able to provide written Informed Consent

Exclusion Criteria:

BMI more than 35
Presence of hydrosalpinx on ultrasound
FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
Known allergic reactions to the planned medications
Use of testicular sperm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women suffering from infertility

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
Danish Fertility Clinic		Frederiksberg	Copenhagen		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided