NCT04227171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

January 5, 2020

Last Update Submit

August 6, 2020

Conditions

Infertile Women Undergoing IVF or ICSI

Outcome Measures

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

    after OPU, normally 2 weeks

Secondary Outcomes (11)

  • Oocyte maturity quality

    after OPU, normally 2 weeks

  • Total dose (IU) of Follitrope™ PFS administered

    2 weeks

  • Total duration (days) of Follitrope™ PFS administered

    2 weeks

  • E2 concentration on hCG day

    normally 10 days

  • P4 concentration on hCG day

    normally 10 days

  • +6 more secondary outcomes

Study Arms (1)

FSH only

GnRH agonist protocol \& GnRH antagonist protocol

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Maria Fertility Hospital

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 13, 2020

Study Start

August 3, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)