ProgesteroneNCT02323347
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
An observational study of Progesterone and Fertilization in Vitro, run by Fundacion Dexeus.
Trial summary
At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled? Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Progesterone, Fertilization in Vitro, Infertility
- What is being tested?
- Progesterone
- How many people
- 1,901 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2014
- Phase
- Observational
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing IVF-ICSI ad fresh embryo transfer
Who may be able to join
- Fresh embryo transfer
- Progesterone value on day HCG (Human choriogonadotrophin hormone)
Who cannot join
- Clinical indication for delaying embryo transfer
About this study
At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?
Read the detailed description
There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.
- Conditions
- Progesterone, Fertilization in Vitro, Infertility, Pregnancy
- Being tested
- Progesterone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneOther
Progesterone level
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Measured: 6 weeks after embryo transfer procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProgesteroneStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francisca Martínez, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323347
- Sponsor's protocol ID
- PROGEDEX2014
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez F, Rodriguez I, Devesa M, Buxaderas R, Gomez MJ, Coroleu B. Should progesterone on the human chorionic gonadotropin day still be measured? Fertil Steril. 2016 Jan;105(1):86-92. doi: 10.1016/j.fertnstert.2015.09.008. Epub 2015 Oct 9.
PubMed 26453983
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
- ClinicalTrials.gov ID
- NCT02323347
- Acronym / sponsor ID
- PROGEDEX2014
- Conditions
- Progesterone, Fertilization in Vitro, Infertility, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,901 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Dec 2014 (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.
At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?
Detailed description
There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF-ICSI ad fresh embryo transfer
Key inclusion criteria (2 listed)
- Fresh embryo transfer
- Progesterone value on day HCG (Human choriogonadotrophin hormone)
Key exclusion criteria (1 listed)
- Clinical indication for delaying embryo transfer
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 |
|---|---|---|
| ProgesteroneProgesterone level | Other | – |
Primary outcome
Clinical Pregnancy
Time frame: 6 weeks after embryo transfer procedure
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 23 Dec 2014.
- Derived from this study: PubMed 26453983Martinez F, Rodriguez I, Devesa M, Buxaderas R, Gomez MJ, Coroleu B. Should progesterone on the human chorionic gonadotropin day still be measured? Fertil Steril. 2016 Jan;105(1):86-92. doi: 10.1016/j.fertnstert.2015.09.008. Epub 2015 Oct 9.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Progesterone and Fertilization in Vitro, run by Fundacion Dexeus.
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 2 inclusion and 1 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Clinical Pregnancy (time frame: 6 weeks after embryo transfer procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323347, which also lists 1 linked publication.
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 23 Dec 2014.