Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT02458768
Eligibility Criteria:
Inclusion Criteria:
* Adult women from 20 through 39 years of age at the screening
* Subjects with the mean menstrual cycle day (MCD) of 25 to 35 days
* Subjects with the Follicle Stimulating Hormone (FSH) concentration at the screening not exceeding the upper limit of the normal range (ULN)
* Those diagnosed with infertility due to at least one of the following causes of infertility
* Fallopian tubal factor
* Infertility due to unknown cause
* Male infertility
* Complex factor
* Subjects with the normal ovarian and uterine function
* Subjects with not more than 3 times of the prior experience of in vitro fertilization
* Subjects who had neither administered clomiphene citrate within 30 days nor gonadotropin within 14 days of the IP administration day
* Subjects who were informed on the objective, method and effect etc. of the clinical study and signed the informed consent form
Exclusion Criteria:
* Subjects contraindicated to pregnancy
* Subjects with BMI \> 30 (BMI; kg/m2)
* Subjects diagnosed with polycystic ovary syndrome (PCOS)
* Subjects who had experienced previously at least Grade 4 ovarian hyperstimulation syndrome (OHSS)
* Subjects with poor response to gonadotropin (According to the Bologna criteria\* below) \*At least two of the following three features must be present:
① Advanced maternal age (\>=40 years) or any other risk factor for Poor Ovarian Response (POR)
② A previous POR (\<=3 oocyte with a conventional stimulation protocol)
③ An abnormal ovarian reserve test (i.e. Antral follicle Count (AFC) \< 5 follicles or Anti-Mullerian hormone (AMH) \< 0.5 ng/ml)
* Those with abnormal metrorrhagia due to unknown cause at the screening
* Subjects with submucosal uterine leiomyoma
* Subjects with at least borderline ovarian tumor
* Subjects with a history or malignant tumor in breast
* Subjects with hydrosalpinx not removed by operation
* Subjects with the Thyroid Stimulating Hormone (TSH) level out of the normal range at the screening
* Subjects with a history of malignant tumor within 5 years prior to the screening
* Subjects with severe disease potentially affecting the study such as pituitary insufficiency upon the investigator's judgment (e.g., heart failure, renal failure, hepatic failure or adrenal insufficiency etc.)
* Subject with HIV- or syphilis-positive result at the screening
* Subjects with a psychiatric disorder at the screening or those who failed in understanding the objective and method of this clinical study
* Subject diagnosed with alcohol or drug abuse within 3 months prior to the screening
* Subjects with a history of hypersensitivity to the investigational products of this clinical study
* Subjects with a current or history of thromboembolism in vein or artery
* Subjects with a history of genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
* Subjects who had participated in another clinical study related to a drug administration after the enrollment in this study or who had participated in another clinical study within 3 months prior to the enrollment in this study
* Others including the subjects for whom it was considered difficult to conduct this clinical study upon the principal investigator's judgment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT02458768
Study Brief:
Protocol Section:
NCT02458768