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OpenTrials
Completed

NCT Number: NCT04227171

Observational Study to Develop Dosing Chart

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.

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Key information

Conditions

Infertile Women Undergoing IVF or ICSI

Age range

19 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul Maria Fertility Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: after OPU, normally 2 weeks

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

Secondary outcomes

  1. Oocyte maturity quality

    Time frame: after OPU, normally 2 weeks

    Metaphase II oocytes (%, ICSI only)

  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

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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