Clinical trial NCT03858049: Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: Frozen-thawed embryo transfer
Infertility
Crinone
Duphaston
Chinese population
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-02-28
Enrollment: 172
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: 8 to 10 weeks after embryo transfer
Secondary outcomes:
measure: Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate
timeFrame: 2 weeks after embryo transfer
measure: Implantation Rate
timeFrame: 4-6 weeks after embryo transfer
measure: Clinical Pregnancy Rate
timeFrame: 4-6 weeks after embryo transfer
measure: Early Abortion Rate
timeFrame: Time from embryo transfer to 12 weeks of pregnancy
measure: Luteal Phase Bleeding Rate
timeFrame: 2, 5 and 9 weeks after embryo transfer
measure: Vaginal Bleeding Rate
timeFrame: 5 and 9 weeks after embryo transfer
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: