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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT03387059
Eligibility Criteria:
Inclusion Criteria:
* All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization in Vitro and Embryo Transfer (FIVET)
* Less than or equal to (\<=) 1 previous failed embryo transfer
* Eumenorrheic normo-gonadotropic women
* Basal follicle-stimulating hormone (FSH) \<=12 International unit per liter (IU/L)
* Anti-mullerian hormone (AMH) greater than (\>) 1.1 nanogram per milliliter (ng/mL)
* Ovarian Reserve: number of antral follicles 2 millimeter (mm) between 6 \<= antral follicle count (AFC) \<= 16
* Follicles \> 16 mm at the triggering day between 5-14
* Body Mass Index (BMI) between 18 \<= BMI \<= 27 kilogram per meter square (kg/m\^2)
* Indication for Fresh Embryo transfer
* Normal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)
* Undergoing Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering
* Progesterone (P4) serum level at the HCG triggering day \<= 1.5 ng/mL (Day O/Randomization)
* Estradiol (E2) \<= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin (HCG) triggering day (Day 0/Randomization)
* Subjects must have read and signed the Informed Consent Form prior to study-specific-procedures not part of standard of care
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Clinically significant systemic disease (such as diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy)
* Polycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European Society of Human Reproduction and Embryology \[ESHRE\]/American Society for Reproductive Medicine \[ASRM\], 2003)
* Poor ovarian response (POR) according to the European Society of Human Reproduction and Embryology (ESHRE) Criteria
* RIF (repeated implantation failure), defined as greater than or equals to (\>=) 2 previous failed embryo transfers
* Endometriosis III-IV stage or adenomyosis
* Clinically significant findings on exam or ultrasound, such as salpingitis, hydrosalpynx or evidence of ovarian cysts
* Known hypersensitivity to any of the components of the solution
* Known hypersensitivity to vaginal progesterone or its excipients
* Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
41 Years
Study:
NCT03387059
Study Brief:
Protocol Section:
NCT03387059