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Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858049
Recruitment Status : Recruiting
First Posted : February 28, 2019
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Merck Serono Co., Ltd.
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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).

Condition or disease Intervention/treatment Phase
Infertility Drug: Crinone Drug: Duphaston Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 17, 2022
Estimated Study Completion Date : May 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Crinone Drug: Crinone
Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.

Experimental: Crinone plus Duphaston 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Implantation Rate [ Time Frame: Day 35 ]
    The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858049


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

Locations
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China
Peking University Third Hospital Recruiting
Beijing, China, 100191
Contact: Jie Qiao    +86(010)8 22 66 69      
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Serono Co., Ltd.
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
Additional Information:
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03858049    
Other Study ID Numbers: MS200113_0005
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck KGaA, Darmstadt, Germany:
Frozen-thawed embryo transfer
Infertility
Crinone
Duphaston
Chinese population
Additional relevant MeSH terms:
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Infertility
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs