A Study on Efficacy and Safety of Menopur® Multidose in K... | NCT02835469

Studies
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility

NCT02835469

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

412Actual

Phase

Not provided

Conditions

Infertility

Interventions

Menotrophin

Countries

South Korea

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 2019

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

Jun 2016Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Jun 28, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 18, 2016Estimated

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

Mar 27, 2019

Last Update Posted Date

Mar 28, 2019Actual

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

412Actual

Label	Type	Description	Intervention Names
Menopur® Multidose		Treatment according to routine clinical practice.	Drug: Menotrophin

Name	Type	Description	Arm Group Labels	Other Names
Menotrophin	Drug		Menopur® Multidose	Menopur® Multidose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate	Defined as presence of at least 1 intrauterine pregnancy with a viable fetus	10-11 weeks after embryo transfer

Secondary Outcomes

Measure	Description	Time Frame
Mean Follicle Stimulating Hormone (FSH) level		At baseline and last stimulation day (max 20 days after start of stimulation)
Mean Luteinizing Hormone (LH) level		At baseline and last stimulation day (max 20 days after start of stimulation)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Decision made to prescribe Menopur® multidose according to Summary of product characteristics
The study cycle will be either
- 1st controlled ovarian stimulation cycle ever, or
- 2nd controlled ovarian stimulation cycle ever, or
- 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)

Exclusion Criteria:

Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
Diagnosed as "poor responder", defined as either
- >20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
- any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
- development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
Ovarian hyperstimulation syndrome (OHSS)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Fertility clinics

Sampling Method

Non-Probability Sample

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

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