Status:
TERMINATED
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Infertility
Eligibility:
FEMALE
20-38 years
Phase:
PHASE4
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT03858049
Start Date
May 31 2019
End Date
October 27 2021
Last Update
March 12 2024
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China, 100191