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

NCT03387059_exc_T1
Condition
systemic disease
NCT03387059_exc_T2
Qualifier
Clinically significant
NCT03387059_exc_T3
Condition
diabetes
NCT03387059_exc_T4
Condition
metabolic syndrome
NCT03387059_exc_T5
Condition
immunological diseases
NCT03387059_exc_T6
Condition
diagnosed thrombophilia
NCT03387059_exc_T7
Condition
porphyria
NCT03387059_exc_T8
Condition
medical condition
NCT03387059_exc_T9
Drug
low-molecular weight heparin
NCT03387059_exc_T10
Scope
diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy
NCT03387059_exc_T11
Scope
Clinically significant systemic disease
NCT03387059_exc_T12
Condition
Polycystic ovary syndrome (PCOS)
NCT03387059_exc_T13
Qualifier
Rotterdam Consensus Criteria
NCT03387059_exc_T14
Qualifier
European Society of Human Reproduction and Embryology [ESHRE]/American Society for Reproductive Medicine [ASRM], 2003
NCT03387059_exc_T15
Condition
Poor ovarian response (POR)
NCT03387059_exc_T16
Qualifier
European Society of Human Reproduction and Embryology (ESHRE) Criteria
NCT03387059_exc_T17
Condition
RIF (repeated implantation failure)
NCT03387059_exc_T18
Value
greater than or equals to (>=) 2
NCT03387059_exc_T19
Measurement
previous failed embryo transfers
NCT03387059_exc_T20
Condition
Endometriosis
NCT03387059_exc_T21
Qualifier
III-IV stage
NCT03387059_exc_T22
Condition
adenomyosis
NCT03387059_exc_T23
Qualifier
Clinically significant
NCT03387059_exc_T24
Procedure
exam
NCT03387059_exc_T25
Procedure
ultrasound
NCT03387059_exc_T26
Condition
salpingitis
NCT03387059_exc_T27
Condition
hydrosalpynx
NCT03387059_exc_T28
Condition
ovarian cysts
NCT03387059_exc_T29
Mood
evidence
NCT03387059_exc_T30
Scope
exam or ultrasound
NCT03387059_exc_T31
Observation
findings
NCT03387059_exc_T32
Scope
Clinically significant findings on exam or ultrasound
NCT03387059_exc_T33
Scope
salpingitis, hydrosalpynx or evidence of ovarian cysts
NCT03387059_exc_T34
Condition
hypersensitivity
NCT03387059_exc_T37
Condition
hypersensitivity
NCT03387059_exc_T35
Drug
vaginal progesterone
NCT03387059_exc_T38
Drug
excipients
NCT03387059_exc_T39
Drug
components of the solution