Observational Study to Develop Dosing Chart

Completed

• Conditions: Infertile Women Undergoing IVF or ICSI

• Registration Number: NCT04227171
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-03
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 534

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fertilization rate	1~2 days after OPU
Total dose (IU) of Follitrope™ PFS administered	2 weeks
Number of embryo transferred	3~5 days after OPU
Total duration (days) of Follitrope™ PFS administered	2 weeks
Oocyte maturity quality	after OPU, normally 2 weeks	Metaphase II oocytes (%, ICSI only)
E2 concentration on hCG day	normally 10 days
P4 concentration on hCG day	normally 10 days
Implantation rate	24 days after OPU
Biochemical pregnancy rate	10 days after OPU
clinical pregnancy rate	24 days after OPU
pregnancy rate	up to 10 weeks after OPU

Trial Locations

Locations (1)

Seoul Maria Fertility Hospital; 🇰🇷 Seoul, Korea, Republic of