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

NCT04227171•LG Chem

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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.

Eligibility

Age

19 - 39 years

Sex

FEMALE

Healthy Volunteers

Yes

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

Locations (1)

Seoul Maria Fertility Hospital

Seoul, South Korea

Key Dates

Start Date

August 3, 2018

Primary Completion Date

July 31, 2020

Completion Date

July 31, 2020

Last Updated

August 7, 2020

Enrollment

534

ACTUAL participants

Conditions

Infertile Women Undergoing IVF or ICSI

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COMPLETEDNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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