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:
NCT01121666
Eligibility Criteria:
Inclusion Criteria:
* Age between 20 and 38 years with regular menstrual cycles of 25-35 days
* First or second cycle in the present series of ART
* BMI ≥ 18 ≤ 30 kg/m2
* Basal FSH \< 10 IU/L (cycle day 2-5)
* E2 levels \< 50pg/mL (\< 0.18 nmol/L) at the day of FSH administration
* Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)
* Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility
* Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)
* Willingness to participate in the study and to comply with the study protocol
* Informed consent
Exclusion Criteria:
* Presence of pregnancy
* History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Presence of uncontrolled endocrine disorder
* Previous history or presence of severe ovarian hyperstimulation syndrome
* Presence of polycystic ovaries (PCO)
* Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
* Neoplasia, including tumors of the hypothalamus and pituitary gland
* Abnormal bleeding of undetermined origin
* History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
* Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)
* Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening
* Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)
* History of drug, nicotine or alcohol abuse within the last 12 months (\> 10 cigarettes/day)
* Administration of other investigational products within the last month
* Clinically abnormal findings at Visit 1
* Planned PGS/PGD/PBB or assisted hatching
* Concomitant participation in an other study protocol
* History of extrauterine pregnancy in the previous 3 months
* Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)
* Presence or history of thrombophlebitis or thromboembolic disorders
* Presence or history of cerebral haemorrhage
* Presence or history of porphyria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
38 Years
Study:
NCT01121666
Study Brief:
Protocol Section:
NCT01121666