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

LG Chem1 site in 1 country534 target enrollmentAugust 3, 2018

ConditionsInfertile Women Undergoing IVF or ICSI

Overview

Phase: N/A
Intervention: Not specified
Conditions: Infertile Women Undergoing IVF or ICSI
Sponsor: LG Chem
Enrollment: 534
Locations: 1
Primary Endpoint: No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2018

End Date

July 31, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

LG Chem

Responsible Party

Sponsor

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