Observational Study to Develop Dosing Chart (NCT04227171) | Clinical Trial Compass
CompletedNot Applicable
Observational Study to Develop Dosing Chart
South Korea534 participantsStarted 2018-08-03
Plain-language 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.
Who can participate
Age range
19 Years – 39 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved