InfertilityPhase 4NCT03858049
Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)
A Phase 4 study testing Crinone and Duphaston in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Crinone and Duphaston
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2019to 27 Oct 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Infertility
- Being tested
- Crinone, Duphaston
- Keywords
- Frozen-thawed embryo transfer, Infertility, Crinone, Duphaston, Chinese population
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrinoneDrug
Participants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
DuphastonDrug
Participants received 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoign pregnancy was confirmed up to Day 63.
| Study group | Role | What they receive |
|---|---|---|
| Crinone | Experimental | Participants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63. Receives: Drug: Crinone |
| Crinone plus Duphaston | Experimental | Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63. Receives: Drug: Crinone; Drug: Duphaston |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
Ongoing pregnancy was assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy (8 to 10 weeks after embryo transfer). Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100.
Measured: 8 to 10 weeks after embryo transfer
Secondary outcomes (6)
Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate
Beta-hCG positive rate defined as number of participants with positive beta-hCG divided by the number of participants with embryo transfer (ET) multiplied by 100.
Measured: 2 weeks after embryo transfer
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100.
Measured: 4-6 weeks after embryo transfer
Clinical Pregnancy Rate
Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical pregnancy rate was measured as the number of participants with clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100.
Measured: 4-6 weeks after embryo transfer
Early Abortion Rate
Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age. Early abortion rate defined as the number of participants with early abortion divided by number of participants with clinical pregnancy multiplied by 100.
Measured: Time from embryo transfer to 12 weeks of pregnancy
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 participants with Luteal phase bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.
Measured: 2, 5 and 9 weeks after embryo transfer
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 participants with vaginal bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.
Measured: 5 and 9 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start31 May 2019
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858049
- Sponsor's protocol ID
- MS200113_0005
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2019
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03858049
- Acronym / sponsor ID
- MS200113_0005
- Conditions
- Infertility
- Keywords
- Frozen-thawed embryo transfer, Infertility, Crinone, Duphaston, Chinese population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 May 2019 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crinone | Experimental | Drug: CrinoneParticipants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63. |
| Crinone plus Duphaston | Experimental | Drug: Crinone, Drug: DuphastonParticipants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrinoneParticipants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63. | Drug | Crinone, Crinone plus Duphaston |
| DuphastonParticipants received 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoign pregnancy was confirmed up to Day 63. | Drug | Crinone plus Duphaston |
Primary outcome
Ongoing Pregnancy Rate
Time frame: 8 to 10 weeks after embryo transfer
Ongoing pregnancy was assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy (8 to 10 weeks after embryo transfer). Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100.
6 secondary outcomes
Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate
Time frame: 2 weeks after embryo transfer
Implantation Rate
Time frame: 4-6 weeks after embryo transfer
Clinical Pregnancy Rate
Time frame: 4-6 weeks after embryo transfer
Early Abortion Rate
Time frame: Time from embryo transfer to 12 weeks of pregnancy
Luteal Phase Bleeding Rate
Time frame: 2, 5 and 9 weeks after embryo transfer
Vaginal Bleeding Rate
Time frame: 5 and 9 weeks after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crinone and Duphaston in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy Rate (time frame: 8 to 10 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.