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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03349905
Eligibility Criteria:
Inclusion Criteria:
* Women \[18 - 40\[years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
* Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
* Absence of any medical condition in which pregnancy is contraindicated
* Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection (ICSI) will be allowed during this trial
* Body mass index 18 to 35 kg/m2, inclusive
* Able to understand the study
* Affiliation with a social security scheme
* Dated and signed inform consent
Exclusion Criteria:
* Altered ovarian reserve (Day3: FSH \>12 UI/l; AMH\<1,0 ng/ml; AFC\<8)
* History or presence of tumours of the hypothalamus or pituitary gland
* Presence of non isolated uni- or bilateral hydrosalpinx
* Abnormal gynaecological bleeding of undetermined origin
* Contraindication to being pregnant and/or carrying a pregnancy to term
* Known infection with human immunodeficiency virus, active hepatitis B or C virus in the female or male partner
* History or presence of ovarian, uterine or mammary cancer
* Known allergy or hypersensitivity to human gonadotropin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
* Substance abuse that would interfere with trial conduct, as determined by the investigator
* Use of testicular or epididymal sperm
* Pregnant patient, nursing patient
* Participation in another ART clinical trial within the past 30 days
* Women who have risk to develop severe ovarian hyperstimulation syndrome (OHSS) during controlled ovarian stimulation (COS) defined as ≥ 18 follicles measuring 10 - 14 mm on the day of triggering
* Women with less than 3 follicles ≥ 15 mm on the triggering day or the day before the triggering
* Women with premature progesterone elevation during COS ( ≥1.5 ng/ml)
* Women with uterine polyps diagnosed during COS
* Participation with another interventional study involving human subjects
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03349905
Study Brief:
Protocol Section:
NCT03349905