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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01152866
Eligibility Criteria:
Inclusion Criteria:
* Infertile women desiring a pregnancy
* Subjects whose baseline hormonal values were within normal ranges as per local practice
* Subjects who were willing and able to comply with the protocol for the duration of the study
* Subjects who had given written informed consent, prior to treatment, with the understanding that consent might be withdrawn at any time without prejudice
Exclusion Criteria:
* Subjects with clinically significant disease
* Subjects who were known to be infected by human immunodeficiency virus (HIV), Hepatitis B or C
* Subjects who had any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism or excretion of study drug
* Subjects with severe endometriosis
* Subjects with abnormal, undiagnosed gynaecological bleeding
* Subjects who had any contra-indication to being pregnant or carrying a pregnancy to term
* Subjects who were pregnant or breast-feeding at the beginning of the cycle. Confirmation that the subject was not pregnant was to be established by a negative urine or serum pregnancy test in the 7 days prior to Study Day1
* Subjects with prior hypersensitivity to hCG preparations or one of their excipients
* Subjects with uncontrolled thyroid or adrenal dysfunction
* Subjects with uncontrolled organic intracranial lesion such as a pituitary tumour
* Subjects with ovarian cyst or enlargement of undetermined origin
* Subjects with sex hormone dependent tumors of the reproductive organs and breasts
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01152866
Study Brief:
Protocol Section:
NCT01152866