Observational Study to Develop Dosing Chart | NCT04227171

Studies
Observational Study to Develop Dosing Chart

NCT04227171

Sponsor

LG Chem

Status

Completed

Last Update Posted

Aug 7, 2020Actual

Enrollment

534Actual

Phase

Not provided

Conditions

Infertile Women Undergoing IVF or ICSI

Interventions

Not provided

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

Aug 2020

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

Aug 3, 2018Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Jan 5, 2020

First Submission Date that Met QC Criteria

Jan 9, 2020

First Posted Date

Jan 13, 2020Actual

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 6, 2020

Last Update Posted Date

Aug 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.

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

Yes

Target Follow-Up Duration

10 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

534Actual

Label	Type	Description	Intervention Names
FSH only		GnRH agonist protocol & GnRH antagonist protocol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved	Number of oocyte identified by ovum pick up (OPU) after overovulation	after OPU, normally 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Oocyte maturity quality	Metaphase II oocytes (%, ICSI only)	after OPU, normally 2 weeks
Total dose (IU) of Follitrope™ PFS administered		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female aged of 19 to 39 years
Mean menstrual cycle in 25 to 35 days
Patients to whom Follitrope PFS will be administered in those scheduled to undergo the IVF-ET according to the GnRH agonist or antagonist protocol
In the past continuous IVF cycle failure less than 2 times

Exclusion Criteria:

Patients having a history of ovarian, breast, uterus, hyperthalamus, or pituitary tumor
Abnormal uterine bleeding of undetermined origin
Prior hypersensitivity to a component of recombinant FSH
Ovarian cyst or enlargement of undetermined origin
Clinically significant endocrine abnormalities
Patients having polycystic ovary syndrome (PCOS) history
Poor Ovarian responder (Bologna criteria)
Patients who received Clomiphene citrate, Letrozole (Pemara), or Gonadotropin within 30 days prior to enrollment in this study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection (ICSI) for controlled ovarian stimulation

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided