Observational Study to Develop Dosing Chart

NCT ID: NCT04227171

Last Updated: 2020-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Infertile Women Undergoing IVF or ICSI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FSH only

GnRH agonist protocol \& GnRH antagonist protocol

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul Maria Fertility Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-FSOS002

Identifier Type: -

Identifier Source: org_study_id

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