IVF - Luteal Phase Support After Embryo TransferPhase 4NCT00708539
A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
A Phase 4 study testing progesterone in people with IVF - Luteal Phase Support After Embryo Transfer, run by Nordica Fertility Clinic at 17 sites in 2 countries.
Trial summary
To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- IVF - Luteal Phase Support After Embryo Transfer
- What is being tested?
- progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,686 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Apr 2006to Dec 2008
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years
- Regular menstrual cyclus 25-35 days
- both ovaries present
- No more than 2 previous IVF attempts
- Have given written informed consent
Who cannot join
- More than 2 previous attempts
- Known drug abuse
- Known allergies to the study medication
- No embryo transfer performed in the study cycle
- Previous participating in the study
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Denmark12 sites, 11 recruiting
- Terminated
Faurskov fertility clinic
Aalborg, 9000
- Recruiting
Brædstrup Sygehus
Brædstrup, 8740
Finn Hald
- Recruiting
Dronninglund sygehus
Dronninglund, 9330
Michael Aasted
- Recruiting
Dansk Fertilitetsklinik
Frederiksberg, 2000
Hans Krogh
- Recruiting
Herlev Hospital
Herlev, 2730
Jan Blaabjerg
- Recruiting
Holbæk Sygehus
Holbæk, 4300
Helle E Bredkær
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Helle Meinertz
- Recruiting
Rigshospitalet
København Ø, 2100
Anders N Andersen
- Recruiting
Odense IVF
Odense, 5000
Sven Rex
- Recruiting
Odense OUH
Odense, 5000
Lars Westergaard
- Recruiting
Roskilde Sygehus
Roskilde, 4000
Anette Lindhard
- Recruiting
Skive sygehus
Skive, 7800
Peter Humaidan
Sweden5 sites, 5 recruiting
- Recruiting
Reproduktionscentrum, Sahlgrenska
Gothenburg
- Recruiting
Karolinska
Huddinge
- Recruiting
RMC
Malmö
- Recruiting
Reproduktionscentrum
Stockholm
- Recruiting
Norrlandsuniversitets sjukhus
Umeå
About this study
To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.
- Being tested
- progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Also called crinone 8%
90 mg, vaginal, once daily
ProgesteroneDrug
Also called Progestan in Denmark, Progesterone mic in Sweden
200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Crinone vaginal gel 8% 90 mg once daily Receives: Drug: progesterone |
| 2 | Active comparator | Progesterone mic 400 mg three times daily Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence in ongoing pregnancy per embryo transfer between the two groups
Measured: week 5 after embryo tranfer
Secondary outcomes (1)
Convenience for the patient
Measured: the treatment period (from the day of embryo transfer and 19 days ahead)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startApr 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVF - Luteal Phase Support After Embryo TransferStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordica Fertility Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Investigators
- Svend Lindenberg, Principal investigator, Nordica FertilityclinicSvend Lindenberg, Principal investigator, Nordica Fertility Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708539
- Sponsor's protocol ID
- 25921
- Other IDs
- Eudra CT nr.2005-001248-22
- Status last verified
- Jul 2008
- First submitted
- 27 Jun 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.
- ClinicalTrials.gov ID
- NCT00708539
- Acronym / sponsor ID
- 25921
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,686 participants (estimated)
- Lead sponsor
- Nordica Fertility ClinicUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 2 Jul 2008 (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.
To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: progesteroneCrinone vaginal gel 8% 90 mg once daily |
| 2 | Active comparator | Drug: ProgesteroneProgesterone mic 400 mg three times daily |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-40 years
- Regular menstrual cyclus 25-35 days
- both ovaries present
- No more than 2 previous IVF attempts
- Have given written informed consent
Key exclusion criteria (5 listed)
- More than 2 previous attempts
- Known drug abuse
- Known allergies to the study medication
- No embryo transfer performed in the study cycle
- Previous participating in the study
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 |
|---|---|---|
| progesteroneAlso: crinone 8%90 mg, vaginal, once daily | Drug | 1 |
| ProgesteroneAlso: Progestan in Denmark, Progesterone mic in Sweden200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden | Drug | 2 |
Primary outcome
Equivalence in ongoing pregnancy per embryo transfer between the two groups
Time frame: week 5 after embryo tranfer
1 secondary outcome
Convenience for the patient
Time frame: the treatment period (from the day of embryo transfer and 19 days ahead)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
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.
Svend Lindenberg principal investigator
Nordica Fertilityclinic
Svend Lindenberg principal investigator
Nordica Fertility Clinic
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing progesterone in people with IVF - Luteal Phase Support After Embryo Transfer, run by Nordica Fertility Clinic at 17 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Denmark, Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svend Lindenberg (004533257000, svend@lindenberg.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence in ongoing pregnancy per embryo transfer between the two groups (time frame: week 5 after embryo tranfer). 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 2 Jul 2008; AzTrials last refreshed its copy on 29 Oct 2026.