SterilityPhase 4NCT01430650
Endometrial Priming for Embryo Transfer
A Phase 4 study testing Oral strogen and Transdermal strogen in people with Sterility, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The aim of this trial is compare two different endometrial priming protocols women that receive oral estrogens women that receive transdermal estrogens Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- Oral strogen and Transdermal strogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Jul 2015
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18-50 years old with desire of children and needs of embryo transfer.
- Plasma prolactin less than 30.
- Uterine cavity that allow pregnancy, body mass index between 20-30.
- And signed consent inform.
Who cannot join
- History of estrogen dependent cancer, unknown origin vaginal bleeding.
- Ovarian cyst.
- Contraindications to be pregnant.
- Estrogen allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.
The aim of this trial is compare two different endometrial priming protocols
- women that receive oral estrogens
- women that receive transdermal estrogens
- Conditions
- Sterility
- Being tested
- Oral strogen, Transdermal strogen
- Keywords
- Oral estrogens, transdermal estrogens, endometrial priming
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral strogenDrug
2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.
Transdermal strogenDrug
One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.
| Study group | Role | What they receive |
|---|---|---|
| Oral strogen | Experimental | Not described Receives: Drug: Oral strogen |
| Transdermal strogen | Experimental | Not described Receives: Drug: Transdermal strogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between day means in endometrial priming to achieve 7 mm.
Measured: 11-16 days
Secondary outcomes (2)
Biochemical Pregnancy rate
To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.
Measured: 26-30 days
The patient's adherence to the recommended treatment.
Measured: 1-16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startJul 2010
- Primary completionOct 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Angel Checa, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430650
- Sponsor's protocol ID
- UREP-PREPENDO-2010
- Status last verified
- Sep 2017
- First submitted
- 20 Jun 2011
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.
- ClinicalTrials.gov ID
- NCT01430650
- Acronym / sponsor ID
- UREP-PREPENDO-2010
- Conditions
- Sterility
- Keywords
- Oral estrogens, transdermal estrogens, endometrial priming
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Sep 2011 (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.
The aim of this trial is compare two different endometrial priming protocols
- women that receive oral estrogens
- women that receive transdermal estrogens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral strogen | Experimental | Drug: Oral strogen |
| Transdermal strogen | Experimental | Drug: Transdermal strogen |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 18-50 years old with desire of children and needs of embryo transfer.
- Plasma prolactin less than 30.
- Uterine cavity that allow pregnancy, body mass index between 20-30.
- And signed consent inform.
Key exclusion criteria (4 listed)
- History of estrogen dependent cancer, unknown origin vaginal bleeding.
- Ovarian cyst.
- Contraindications to be pregnant.
- Estrogen allergy.
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 |
|---|---|---|
| Oral strogen2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16. | Drug | Oral strogen |
| Transdermal strogenOne patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16. | Drug | Transdermal strogen |
Primary outcome
Difference between day means in endometrial priming to achieve 7 mm.
Time frame: 11-16 days
2 secondary outcomes
Biochemical Pregnancy rate
Time frame: 26-30 days
The patient's adherence to the recommended treatment.
Time frame: 1-16 days
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 20 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral strogen and Transdermal strogen in people with Sterility, run by Parc de Salut Mar at 1 site in Spain.
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 4 inclusion and 4 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 20 Sep 2017. 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 Spain. 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?
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?
Difference between day means in endometrial priming to achieve 7 mm. (time frame: 11-16 days). 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 20 Sep 2017.