A Phase 4 interventional study of Crinone and Duphaston in Infertility, sponsored by Merck KGaA, Darmstadt, Germany. Terminated at 1 site in China. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 4, Interventional, and Treatment
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).
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 172 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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Participants are eligible to be included in the study only if all the following criteria apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Crinone
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.
Drug: Crinone · Drug: Duphaston
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.
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.
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.
Time frame: 8 to 10 weeks after embryo transfer
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 5 and 9 weeks after embryo transfer
| Milestone | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Started | 86 | 86 |
| Completed | 69 | 76 |
| Not completed | 17 | 10 |
| Withdrew: Adverse event | 16 | 9 |
| Withdrew: Other | 1 | 1 |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Ongoing Pregnancy Rate | 18.8 (11.2 to 28.8) | 29.1 (19.8 to 39.9) |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate | 37.6 (27.4 to 48.8) | 43.0 (32.4 to 54.2) |
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100.
| percentage of gestational sacs per ET | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Implantation Rate | 20.9 (12.9 to 31.0) | 33.7 (23.9 to 44.7) |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Clinical Pregnancy Rate | 21.2 (13.1 to 31.4) | 33.7 (23.9 to 44.7) |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Early Abortion Rate | 11.1 (1.4 to 34.7) | 13.8 (3.9 to 31.7) |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Luteal Phase Bleeding Rate | 1.2 (0.0 to 6.4) | 3.5 (0.7 to 9.9) |
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.
| Percentage of participants | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Vaginal Bleeding Rate | 7.1 (2.6 to 14.7) | 10.5 (4.9 to 18.9) |
Collected over Day of endometrial transformation (Day -5) up to 12 weeks of pregnancy. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crinone | 0/86 (0%) | 4/86 (4.7%) | 17/86 (19.8%) |
| Crinone® Plus Duphaston | 0/86 (0%) | 4/86 (4.7%) | 14/86 (16.3%) |
| Event | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Decreased embryo viabilityInjury, poisoning and procedural complications | 2/86 | 2/86 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/86 | 2/86 |
| Abortion incompletePregnancy, puerperium and perinatal conditions | 1/86 | 0/86 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 1/86 | 0/86 |
| Event | Crinone | Crinone® Plus Duphaston |
|---|---|---|
| Abortion threatenedPregnancy, puerperium and perinatal conditions | 8/86 | 4/86 |
| Biochemical pregnancyPregnancy, puerperium and perinatal conditions | 8/86 | 3/86 |
| Vaginal haemorrhagePregnancy, puerperium and perinatal conditions | 2/86 | 7/86 |
Intention-to-Treat (ITT) population included all participants who received at least one dose of randomized study intervention.
| Age, Continuous(Years) | Crinone | Crinone® Plus Duphaston | Total |
|---|---|---|---|
| Mean | 30.84 ± 2.918 | 30.74 ± 3.163 | 30.79 ± 3.034 |
| Sex: Female, Male(Participants) | Crinone | Crinone® Plus Duphaston | Total |
|---|---|---|---|
| Female | 86 | 86 | 172 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Crinone | Crinone® Plus Duphaston | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 86 | 86 | 172 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
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
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.
Data sharing details ↗ · bit.ly
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crinone
Merck KGaA, Darmstadt, Germany →