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Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Crinone
Duphaston
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Frozen-thawed embryo transfer, Infertility, Crinone, Duphaston, Chinese population

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Crinone

Crinone plus Duphaston

Arm Description

Outcomes

Primary Outcome Measures

Ongoing Pregnancy Rate
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

Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate
Beta-hCG positive rate defined as the number of Beta-hCG positive participants expressed per 100 embryo transfer cycles.
Implantation Rate
The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred.
Clinical Pregnancy rate
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
Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age.
Luteal Phase Bleeding Rate
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
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.

Full Information

First Posted
February 26, 2019
Last Updated
December 7, 2021
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03858049
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
October 27, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Frozen-thawed embryo transfer, Infertility, Crinone, Duphaston, Chinese population

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crinone
Arm Type
Experimental
Arm Title
Crinone plus Duphaston
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Crinone
Intervention Description
Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.
Intervention Type
Drug
Intervention Name(s)
Duphaston
Intervention Description
Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.
Primary Outcome Measure Information:
Title
Ongoing Pregnancy Rate
Description
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.
Time Frame
8 to 10 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate
Description
Beta-hCG positive rate defined as the number of Beta-hCG positive participants expressed per 100 embryo transfer cycles.
Time Frame
Day 14
Title
Implantation Rate
Description
The number of gestational sacs observed in ultrasound scan divided by the number of embryos transferred.
Time Frame
Day 35
Title
Clinical Pregnancy rate
Description
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.
Time Frame
Day 35
Title
Number of Participants With Early Abortion
Description
Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age.
Time Frame
Up to 12 Weeks
Title
Luteal Phase Bleeding Rate
Description
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.
Time Frame
Up to Day 14
Title
Vaginal Bleeding Rate
Description
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.
Time Frame
Day 14 to Day 63

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200113_0005
Description
Trial Awareness and Transparency website

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Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

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