ProgesteronePENCT04253470
Debate on Progesterone Elevation on the Day of Triggering
An observational study of Progesterone and ART, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology. This is a single-center retrospective cohort study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Progesterone, ART, Female Infertility
- What is being tested?
- embryo transfer
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2012to 1 Oct 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5), and all thawed embryo transfer, except from the ones deriving from PGTA, performed from January 2012 to December 2016 in Humanitas Fertility Center were included.
Who may be able to join
- All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5)
- Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc)
Who cannot join
- thawed embryo transfers deriving from PGTA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neverending Debate on Progesterone Elevation: Possible Solutions
The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology.
This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016.
All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.
- Conditions
- Progesterone, ART, Female Infertility, Embryo Transfer
- Being tested
- embryo transfer
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo transferOther
Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy
| Study group | Role | What they receive |
|---|---|---|
| cleavage stage embryo | embryo which is on day 2 or 3 Receives: Other: embryo transfer | |
| blastocyst embryo | embryo which is on day 5 Receives: Other: embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of PE on CPR and LBR
To evaluate the impact of premature high serum P levels on the outcome of fresh embryo transfer cycles in terms of Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR).
Measured: January 2012-December 2016
Secondary outcomes (1)
Blastocyst embryo transfers' outcomes in PE
Furthermore, the present study retrospectively investigates whether the transfer of blastocysts on day 5 post-fertilization (D5-ET) may improve the CPR and the LBR in patients with P rise.
Measured: January 2012-December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2012
- Primary completion31 Dec 2016
- Study completion1 Oct 2019
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.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raffaella De Cesare, Principal investigator, Humanitas clinical and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253470
- Sponsor's protocol ID
- 2020xxxx
- Acronym
- PE
- Status last verified
- Jan 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Cesare R, Morenghi E, Cirillo F, Ronchetti C, Canevisio V, Persico P, Baggiani A, Sandri MT, Levi-Setti PE. The Role of hCG Triggering Progesterone Levels: A Real-World Retrospective Cohort Study of More Than 8000 IVF/ICSI Cycles. Front Endocrinol (Lausanne). 2020 Sep 23;11:547684. doi: 10.3389/fendo.2020.547684. eCollection 2020.
PubMed 33071968
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neverending Debate on Progesterone Elevation: Possible Solutions
- ClinicalTrials.gov ID
- NCT04253470
- Acronym / sponsor ID
- PE / 2020xxxx
- Conditions
- Progesterone, ART, Female Infertility, Embryo Transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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 association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology.
This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016.
All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cleavage stage embryo | – | Other: embryo transferembryo which is on day 2 or 3 |
| blastocyst embryo | – | Other: embryo transferembryo which is on day 5 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5), and all thawed embryo transfer, except from the ones deriving from PGTA, performed from January 2012 to December 2016 in Humanitas Fertility Center were included.
Key inclusion criteria (2 listed)
- All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5)
- Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc)
Key exclusion criteria (1 listed)
- thawed embryo transfers deriving from PGTA.
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 |
|---|---|---|
| embryo transferStep of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy | Other | blastocyst embryo, cleavage stage embryo |
Primary outcome
Impact of PE on CPR and LBR
Time frame: January 2012-December 2016
To evaluate the impact of premature high serum P levels on the outcome of fresh embryo transfer cycles in terms of Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR).
1 secondary outcome
Blastocyst embryo transfers' outcomes in PE
Time frame: January 2012-December 2016
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 5 Feb 2020.
- Derived from this study: PubMed 33071968De Cesare R, Morenghi E, Cirillo F, Ronchetti C, Canevisio V, Persico P, Baggiani A, Sandri MT, Levi-Setti PE. The Role of hCG Triggering Progesterone Levels: A Real-World Retrospective Cohort Study of More Than 8000 IVF/ICSI Cycles. Front Endocrinol (Lausanne). 2020 Sep 23;11:547684. doi: 10.3389/fendo.2020.547684. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Raffaella De Cesare principal investigator
Humanitas clinical and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progesterone and ART, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 Feb 2020. 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 Italy. 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.
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?
Impact of PE on CPR and LBR (time frame: January 2012-December 2016). 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 NCT04253470, 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 5 Feb 2020.