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CompletedNCT04227171Updated Aug 7, 2020

Observational Study to Develop Dosing Chart

An observational study in Infertile Women Undergoing IVF or ICSI, sponsored by LG Chem. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-07.

Sponsored by LG Chem · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
534
Ages
19 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertile Women Undergoing IVF or ICSI

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 534 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection (ICSI) for controlled ovarian stimulation

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
534 participants (actual)
Target follow-up
10 Weeks
Patient registry
Yes

Groups and cohorts

  • FSH only

    GnRH agonist protocol \& GnRH antagonist protocol

06

What researchers measure

Primary outcomes

  1. No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved

    Number of oocyte identified by ovum pick up (OPU) after overovulation

    Time frame: after OPU, normally 2 weeks

Secondary outcomes

  1. Oocyte maturity quality

    Metaphase II oocytes (%, ICSI only)

    Time frame: after OPU, normally 2 weeks

  2. Total dose (IU) of Follitrope™ PFS administered

    Time frame: 2 weeks

  3. Total duration (days) of Follitrope™ PFS administered

    Time frame: 2 weeks

  4. E2 concentration on hCG day

    Time frame: normally 10 days

  5. P4 concentration on hCG day

    Time frame: normally 10 days

  6. Fertilization rate

    Time frame: 1~2 days after OPU

  7. Number of embryo transferred

    Time frame: 3~5 days after OPU

  8. Implantation rate

    Time frame: 24 days after OPU

  9. Biochemical pregnancy rate

    Time frame: 10 days after OPU

  10. clinical pregnancy rate

    Time frame: 24 days after OPU

  11. pregnancy rate

    Time frame: up to 10 weeks after OPU

07

Study locations

1 site
  • Seoul Maria Fertility Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04227171
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Aug 3, 2018
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020
Last update
Aug 7, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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