Observational Study to Develop Dosing Chart

A Multicenter, Prospective Cohort Observational Study to Develop Dosing Chart Based on Patient Specific Characteristics and Ovarian Response When Follitrope™ PFS is Administered Subcutaneously to Infertility Women Patients

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.

Study Overview

• Status: Completed
• Conditions: Infertile Women Undergoing IVF or ICSI

• Study Type: Observational
• Enrollment (Actual): 534

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul Maria Fertility Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
FSH only; GnRH agonist protocol & GnRH antagonist protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Total duration (days) of Follitrope™ PFS administered		2 weeks
E2 concentration on hCG day		normally 10 days
P4 concentration on hCG day		normally 10 days
Fertilization rate		1~2 days after OPU
Number of embryo transferred		3~5 days after OPU
Implantation rate		24 days after OPU
Biochemical pregnancy rate		10 days after OPU
clinical pregnancy rate		24 days after OPU
pregnancy rate		up to 10 weeks after OPU

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: LG-FSOS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No