InfertilityNCT02129998
The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
An observational study of Infertility, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- IVF/ICSI treatment
- How many people
- 873 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Oct 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.
Who may be able to join
- -All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation.
Who cannot join
- -Prior participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy.
The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development.
IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.
- Conditions
- Infertility
- Being tested
- IVF/ICSI treatment
- Keywords
- Infertility, IVF/ICSI, Progesterone, Preimplantation Factor (PIF)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF/ICSI treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Standard IVF/ICSI treatment | Not described Receives: Other: IVF/ICSI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-going pregnancy rate
Measured: 10th week of gestation
Secondary outcomes (1)
Implantation rate
Measured: 7th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionOct 2017
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals, BioIncept LLC
- Responsible party
- Principal investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129998
- Sponsor's protocol ID
- Progesterone/PIF_Skive
- Status last verified
- Oct 2017
- First submitted
- 1 May 2014
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomsen LH, Kesmodel US, Erb K, Bungum L, Pedersen D, Hauge B, Elbaek HO, Povlsen BB, Andersen CY, Humaidan P. The impact of luteal serum progesterone levels on live birth rates-a prospective study of 602 IVF/ICSI cycles. Hum Reprod. 2018 Aug 1;33(8):1506-1516. doi: 10.1093/humrep/dey226.
PubMed 29955789
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT02129998
- Acronym / sponsor ID
- Progesterone/PIF_Skive
- Conditions
- Infertility
- Keywords
- Infertility, IVF/ICSI, Progesterone, Preimplantation Factor (PIF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals, BioIncept LLC
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 May 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.
The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy.
The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development.
IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard IVF/ICSI treatment | – | Other: IVF/ICSI treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.
Key inclusion criteria (1 listed)
- -All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation.
Key exclusion criteria (1 listed)
- -Prior participation 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 |
|---|---|---|
| IVF/ICSI treatment | Other | Standard IVF/ICSI treatment |
Primary outcome
On-going pregnancy rate
Time frame: 10th week of gestation
1 secondary outcome
Implantation rate
Time frame: 7th week of gestation
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 9 Oct 2017.
- Derived from this study: PubMed 29955789Thomsen LH, Kesmodel US, Erb K, Bungum L, Pedersen D, Hauge B, Elbaek HO, Povlsen BB, Andersen CY, Humaidan P. The impact of luteal serum progesterone levels on live birth rates-a prospective study of 602 IVF/ICSI cycles. Hum Reprod. 2018 Aug 1;33(8):1506-1516. doi: 10.1093/humrep/dey226.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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?
An observational study of Infertility, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
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 1 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 9 Oct 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 Denmark. 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?
On-going pregnancy rate (time frame: 10th week of gestation). 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 NCT02129998, 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 9 Oct 2017.