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The trend in LPS treatment tends to increase the dosage of progesterone in FET-HRT, this study was designed 5 years ago.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crinone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 to 10 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks after embryo transfer |
| Implantation Rate |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100191 | China |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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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
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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crinone | 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. |
| FG001 | Crinone® Plus Duphaston | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-Treat (ITT) population included all participants who received at least one dose of randomized study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Crinone | 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. |
| BG001 | Crinone® Plus Duphaston |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT Population included all participants who received at least one dose of randomized study intervention. Here, "Number of participants analyzed" signified those participants who had embryo transferred. | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 to 10 weeks after embryo transfer |
|
Day of endometrial transformation (Day -5) up to 12 weeks of pregnancy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crinone | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased embryo viability | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2021 | Sep 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2019 | Sep 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C400424 | Crinone |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Duphaston | Drug | 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. |
|
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100. |
| 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. | 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. | 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. | 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. | 5 and 9 weeks after embryo transfer |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Crinone® Plus Duphaston | 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. |
|
|
| Secondary | 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. | ITT Population included all participants who received at least one dose of randomized study intervention. Here, "Number of participants analyzed" signified those participants who had embryo transferred. | Posted | Number | 95% Confidence Interval | Percentage of participants | 2 weeks after embryo transfer |
|
|
|
| Secondary | Implantation Rate | Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100. | ITT Population included all participants who received at least one dose of randomized study intervention. | Posted | Number | 95% Confidence Interval | percentage of gestational sacs per ET | 4-6 weeks after embryo transfer | embroys transferred | embroys transferred |
|
|
|
| Secondary | 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. | ITT Population included all participants who received at least one dose of randomized study intervention. Here, "Number of participants analyzed" signified those participants who had embryo transferred. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4-6 weeks after embryo transfer |
|
|
|
| Secondary | 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. | ITT Population included all participants who received at least one dose of randomized study intervention. Here, "Number of participants analyzed" signified those participants with clinical pregnancy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Time from embryo transfer to 12 weeks of pregnancy |
|
|
|
| Secondary | 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. | Safety analysis set included all participants who have received at least one dose of study intervention. Here, "Number of participants analyzed" signified those participants who had embryo transferred. | Posted | Number | 95% Confidence Interval | Percentage of participants | 2, 5 and 9 weeks after embryo transfer |
|
|
|
| Secondary | 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. | Safety analysis set included all participants who have received at least one dose of study intervention. Here, "Number of participants analyzed" signified those participants who had embryo transferred. | Posted | Number | 95% Confidence Interval | Percentage of participants | 5 and 9 weeks after embryo transfer |
|
|
|
| 0 |
| 86 |
| 4 |
| 86 |
| 17 |
| 86 |
| EG001 | Crinone® Plus Duphaston | 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. | 0 | 86 | 4 | 86 | 14 | 86 |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Biochemical pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA Version 24.0 | Non-systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |