Observational Study to Develop Dosing Chart

LG Chem

Status: Completed

Conditions: Infertile Women Undergoing IVF or ICSI

Study type: Observational

Funder types: Industry

Identifiers

NCT04227171

LG-FSOS002

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: Female

Ages: 19 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

534 participants in 1 patient group

FSH only

Description:

GnRH agonist protocol \& GnRH antagonist protocol