Infertile Women Undergoing IVF or ICSI Clinical Trial
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
| NCT number | NCT04227171 |
| Other study ID # | LG-FSOS002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 3, 2018 |
| Est. completion date | July 31, 2020 |
| Verified date | August 2020 |
| Source | LG Chem |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 534 |
| Est. completion date | July 31, 2020 |
| Est. primary completion date | July 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 39 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul Maria Fertility Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| LG Chem |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Oocyte maturity quality | Metaphase II oocytes (%, ICSI only) | after OPU, normally 2 weeks | |
| Secondary | Total dose (IU) of Follitrope™ PFS administered | 2 weeks | ||
| Secondary | Total duration (days) of Follitrope™ PFS administered | 2 weeks | ||
| Secondary | E2 concentration on hCG day | normally 10 days | ||
| Secondary | P4 concentration on hCG day | normally 10 days | ||
| Secondary | Fertilization rate | 1~2 days after OPU | ||
| Secondary | Number of embryo transferred | 3~5 days after OPU | ||
| Secondary | Implantation rate | 24 days after OPU | ||
| Secondary | Biochemical pregnancy rate | 10 days after OPU | ||
| Secondary | clinical pregnancy rate | 24 days after OPU | ||
| Secondary | pregnancy rate | up to 10 weeks after OPU |