Infertile Women Undergoing IVF or ICSINCT04227171
Observational Study to Develop Dosing Chart
An observational study of Infertile Women Undergoing IVF or ICSI, run by LG Chem at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertile Women Undergoing IVF or ICSI
- How many people
- 534 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2018to 31 Jul 2020
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection (ICSI) for controlled ovarian stimulation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Infertile Women Undergoing IVF or ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FSH only | GnRH agonist protocol \& GnRH antagonist protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved
Number of oocyte identified by ovum pick up (OPU) after overovulation
Measured: after OPU, normally 2 weeks
Secondary outcomes (11)
Oocyte maturity quality
Metaphase II oocytes (%, ICSI only)
Measured: after OPU, normally 2 weeks
Total dose (IU) of Follitrope™ PFS administered
Measured: 2 weeks
Total duration (days) of Follitrope™ PFS administered
Measured: 2 weeks
E2 concentration on hCG day
Measured: normally 10 days
P4 concentration on hCG day
Measured: normally 10 days
Fertilization rate
Measured: 1~2 days after OPU
Number of embryo transferred
Measured: 3~5 days after OPU
Implantation rate
Measured: 24 days after OPU
Biochemical pregnancy rate
Measured: 10 days after OPU
clinical pregnancy rate
Measured: 24 days after OPU
pregnancy rate
Measured: up to 10 weeks after OPU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start3 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Women Undergoing IVF or ICSIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227171
- Sponsor's protocol ID
- LG-FSOS002
- Status last verified
- Aug 2020
- First submitted
- 5 Jan 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04227171
- Acronym / sponsor ID
- LG-FSOS002
- Conditions
- Infertile Women Undergoing IVF or ICSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSH only | – | –GnRH agonist protocol \& GnRH antagonist protocol |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection (ICSI) for controlled ovarian stimulation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Oocyte maturity quality
Time frame: after OPU, normally 2 weeks
Total dose (IU) of Follitrope™ PFS administered
Time frame: 2 weeks
Total duration (days) of Follitrope™ PFS administered
Time frame: 2 weeks
E2 concentration on hCG day
Time frame: normally 10 days
P4 concentration on hCG day
Time frame: normally 10 days
Fertilization rate
Time frame: 1~2 days after OPU
Number of embryo transferred
Time frame: 3~5 days after OPU
Implantation rate
Time frame: 24 days after OPU
Biochemical pregnancy rate
Time frame: 10 days after OPU
clinical pregnancy rate
Time frame: 24 days after OPU
pregnancy rate
Time frame: up to 10 weeks after OPU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Infertile Women Undergoing IVF or ICSI
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
Enrolling by invitation
Purpose to Evaluate the Effectiveness of the Superovulation Stimulation Protocol Using Human Chorionic Gonadotropin (hCG) by Demonstrating Its Equivalence to Standard Controlled Ovarian Stimulation Protocols in Terms of Oocytes Retrieved, Blastulation While Maintaining an Economic Advantage
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
RecruitingObservational study
Comparison of Uterine Distension in Hysterosonography Among Patients Monitored for Infertility
Infertile Women Undergoing IVF or ICSI, Distension by Volumetric Analysis of the Uterus
Not yet recruiting
Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI
Infertile Women Undergoing IVF or ICSI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertile Women Undergoing IVF or ICSI, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved (time frame: after OPU, normally 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.