InfertilityPhase 3NCT01081652
A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
A Phase 3 study testing Micronised Progesterone and Progesterone in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
Trial summary
This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Micronised Progesterone and Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- May 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has given written informed consent
- BMI < 25 kg/m2
- Age < 36 years
- <3 prior ART cycles (IVF, ICSI and related procedures)
- Infertility
- Regular spontaneous ovulatory menstrual cycles
Who cannot join
- Habitual abortion
- Hydrosalpinges
- History of past poor response to COH
- Patients with serious arterial, lung, hepatic and renal diseases
- Hepatic and renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.
Read the detailed description
This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.
- Conditions
- Infertility
- Being tested
- Micronised Progesterone, Progesterone
- Keywords
- Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronised ProgesteroneDrug
Also called Crinone 8%
Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
ProgesteroneDrug
Progesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
| Study group | Role | What they receive |
|---|---|---|
| Crinone 8% group | Experimental | Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally Receives: Drug: Micronised Progesterone |
| Intramuscular progesterone group | Active comparator | Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in hCG positive rate in the two arms 14 days after embryo transfer
The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
The difference in implantation rate in the two arms 30 days 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 posted5 Mar 2010 (estimated)
- Study startMay 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Huafei Li, Study director, Serono Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081652
- Sponsor's protocol ID
- IMP 25347
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
- ClinicalTrials.gov ID
- NCT01081652
- Acronym / sponsor ID
- IMP 25347
- Conditions
- Infertility
- Keywords
- Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- May 2005 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.
Detailed description
This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crinone 8% group | Experimental | Drug: Micronised ProgesteroneFemale subjects undergoing IVF/ET treated with Crinone 8% intravaginally |
| Intramuscular progesterone group | Active comparator | Drug: ProgesteroneFemale subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has given written informed consent
- BMI < 25 kg/m2
- Age < 36 years
- <3 prior ART cycles (IVF, ICSI and related procedures)
- Infertility
Key exclusion criteria (5 listed)
- Habitual abortion
- Hydrosalpinges
- History of past poor response to COH
- Patients with serious arterial, lung, hepatic and renal diseases
- Hepatic and renal impairment
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 |
|---|---|---|
| Micronised ProgesteroneAlso: Crinone 8%Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days. | Drug | Crinone 8% group |
| ProgesteroneProgesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days. | Drug | Intramuscular progesterone group |
Primary outcome
The difference in hCG positive rate in the two arms 14 days after embryo transfer
The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
The difference in implantation rate in the two arms 30 days after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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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.
Huafei Li study director
Serono Pharmaceutical Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronised Progesterone and Progesterone 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference in hCG positive rate in the two arms 14 days after embryo transfer. The study lists 3 primary outcomes in all. 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 31 Jul 2014.