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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT01225835
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
* Aged ≥34 and ≤42 years
* Body mass index of \>18 and \<28 kg/m\^2
* Normal pelvic ultrasound at Screening
* No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic sperm injection (ICSI) in the history of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not count; Clomifen cycles are no exclusion criterion)
* At least 3 consecutive ovulatory menstrual cycles of 24-35 days
* No fertility stimulating drugs at all
* Sperm of partner classified as normal according to World Health Organisation (WHO) 2010 criteria
* Clinically normal baseline haematology, clinical chemistry, and urinalysis values
* Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening
* Endocrine test results within the clinically normal limits at Screening
Exclusion Criteria:
* Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus)
* A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
* A history of coagulation disorders
* Persistent ovarian cysts (\>3 months)
* A history of hypersensitivity to any of the constituents of the study medication or related compounds
* Diagnosed poor (\<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
* History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated assisted reproductive technology (ART)-cycle
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
34 Years
Maximum Age:
42 Years
Study:
NCT01225835
Study Brief:
Protocol Section:
NCT01225835