Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

• ClinicalTrials.gov Identifier: NCT03858049
• Recruitment Status: Recruiting
• First Posted: February 28, 2019
• Last Update Posted: February 10, 2021
• Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd.
• Information provided by (Responsible Party): Merck KGaA, Darmstadt, Germany

Tracking Information

• First Submitted Date: February 26, 2019
• First Posted Date: February 28, 2019
• Last Update Posted Date: February 10, 2021
• Actual Study Start Date: May 31, 2019
• Estimated Primary Completion Date: May 17, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2019)

Ongoing Pregnancy Rate [ Time Frame: 8 to 10 weeks after embryo transfer ]

Ongoing pregnancy will be assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy. Ongoing pregnancy rate is defined as the number of ongoing pregnancies expressed per 100 embryo transfer cycles.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2019)

• Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate [ Time Frame: Day 14 ]
  Beta-hCG positive rate defined as the number of Beta-hCG positive participants expressed per 100 embryo transfer cycles.
• Implantation Rate [ Time Frame: Day 35 ]
  The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred.
• Clinical Pregnancy rate [ Time Frame: Day 35 ]
  A pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical Pregnancy rate defined as the number of clinical pregnancies expressed per 100 embryo transfer cycles.
• Number of Participants With Early Abortion [ Time Frame: Up to 12 Weeks ]
  Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age.
• Luteal Phase Bleeding Rate [ Time Frame: Up to Day 14 ]
  Luteal Phase Bleeding defined as the onset of any bleeding after embryo transfer and prior to the pregnancy test. Luteal Phase Bleeding Rate defined as the number of the participants with luteal phase bleeding expressed per 100 embryos transferred cycles.
• Vaginal Bleeding Rate [ Time Frame: Day 14 to Day 63 ]
  Vaginal bleeding is defined as any bleeding recorded after a pregnancy test via serum Beta-Human Chorionic Gonadotrophin. Vaginal bleeding rate defined as the number of the participants with vaginal bleeding expressed per 100 embryos transferred cycles.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Crinone Versus Combination Medication
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Infertility

Intervention

• Drug: Crinone
  Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.
• Drug: Duphaston
  Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.

Study Arms

• Experimental: Crinone
  Intervention: Drug: Crinone
• Experimental: Crinone plus Duphaston
  Interventions:

  • Drug: Crinone
  • Drug: Duphaston

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 26, 2019): 334
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 17, 2022
• Estimated Primary Completion Date: May 17, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 38 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Communication Center; +49 6151 72 5200; service@emdgroup.com

• Listed Location Countries: China
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT03858049
• Other Study ID Numbers: MS200113_0005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

• Responsible Party: Merck KGaA, Darmstadt, Germany
• Study Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborators: Merck Serono Co., Ltd.

Investigators

• Study Director: Medical Responsible; Merck KGaA, Darmstadt, Germany

• PRS Account: Merck KGaA, Darmstadt, Germany
• Verification Date: February 2021