Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)

MS200113_0005

The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).

2019-05-31

2021-10-27

2021-10-27

Terminated

Early phase I

172

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions * Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site) * Participants have received estradiol valerate for no more than 20 days * Participants have a transitional-endometrium of greater than or equal to 8 millimeter * Participants have normal uterine cavity * Participants can give signed informed consent * Participants are willing to follow the study protocol and able to complete the study Exclusion Criteria: * Participants are willing to follow the study protocol and able to complete the study * Participants with greater than or equal to three previously failed cycles of ET * Participants with diseases that cannot tolerate pregnancy * Hydrosalpinx * Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996) * Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin * History of recurrent miscarriages * Vaginitis * Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions * Known or suspected progestogen-dependent neoplasm * Participation in another clinical trial within the past 30 days * Contraindications of both Crinone and Duphaston

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 172, 'type': 'ACTUAL'}}

2024-03-12