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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04227171

Enrollment

534

Registered

2020-01-13

Start date

2018-08-03

Completion date

2020-07-31

Last updated

2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile Women Undergoing IVF or ICSI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 39 Years

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

Design outcomes

Primary

Measure	Time frame	Description
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved	after OPU, normally 2 weeks	Number of oocyte identified by ovum pick up (OPU) after overovulation

Secondary

Measure	Time frame	Description
clinical pregnancy rate	24 days after OPU	—
pregnancy rate	up to 10 weeks after OPU	—
Oocyte maturity quality	after OPU, normally 2 weeks	Metaphase II oocytes (%, ICSI only)
Total dose (IU) of Follitrope™ PFS administered	2 weeks	—
Total duration (days) of Follitrope™ PFS administered	2 weeks	—
Biochemical pregnancy rate	10 days after OPU	—
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	—
E2 concentration on hCG day	normally 10 days	—

Countries

South Korea

Outcome results