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Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

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

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE May 31, 2019
Estimated Primary Completion Date May 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Crinone Versus Combination Medication
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • 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  ICMJE
  • Experimental: Crinone
    Intervention: Drug: Crinone
  • Experimental: Crinone plus Duphaston
    Interventions:
    • Drug: Crinone
    • Drug: Duphaston
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
334
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2022
Estimated Primary Completion Date May 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com
Listed Location Countries  ICMJE China
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03858049
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Merck KGaA, Darmstadt, Germany
Collaborators  ICMJE Merck Serono Co., Ltd.
Investigators  ICMJE
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP