InfertilityNCT02109900
Prognostic Value of Progesterone on Oocyte Retrieval Day for In Vitro Fertilization Outcome
An observational study of Infertility and Assisted Reproductive Technology, run by Acibadem University.
Trial summary
This observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Assisted Reproductive Technology
- What is being tested?
- Serum Progesterone Levels
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jun 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who are referred to Acibadem Kayseri Hospital IVF Unit
Who may be able to join
- Age < 40 years
- Basal FSH < 12 IU/L
- Basal P < 1.6 ng/mL
Who cannot join
- Women with polycystic ovaries syndrome (PCOS)
- Women with Stage III-IV Endometriosis
- Women with a pathological condition of the adrenal glands
About this study
Official title: Prognostic Value of Progesterone Levels on Oocyte Retrieval Day for Outcome of Intracytoplasmic Sperm Injection
This observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.
There has been evidence, that increased serum levels of progesterone on triggering day are associated with a decreased probability of pregnancy after IVF.
There is no study that investigate assocation between serum progesterone levels on the day of oocyte pick-up and IVF outcomes. This study will be the first in this case.
- Conditions
- Infertility, Assisted Reproductive Technology
- Being tested
- Serum Progesterone Levels
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Progesterone LevelsOther
| Study group | Role | What they receive |
|---|---|---|
| Serum Progesteron Levels | Not described Receives: Other: Serum Progesterone Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Clinical pregnancy, defined as ultrasound evidence of gestational sac at 6 weeks of gestation
Measured: At 6-8 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turgut Aydın, Acibadem University
- Investigators
- Turgut Aydin, Principal investigator, Acıbadem Kayseri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109900
- Sponsor's protocol ID
- OpudayPivfOutcome
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Progesterone Levels on Oocyte Retrieval Day for Outcome of Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT02109900
- Acronym / sponsor ID
- OpudayPivfOutcome
- Conditions
- Infertility, Assisted Reproductive Technology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (estimated)
- First posted
- 10 Apr 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.
This observational study aims the potential role of serum progesterone levels on the day of oocyte pick-up on the probability of pregnancy, in patients undergoing antagonist IVF cycles.
There has been evidence, that increased serum levels of progesterone on triggering day are associated with a decreased probability of pregnancy after IVF.
There is no study that investigate assocation between serum progesterone levels on the day of oocyte pick-up and IVF outcomes. This study will be the first in this case.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum Progesteron Levels | – | Other: Serum Progesterone Levels |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are referred to Acibadem Kayseri Hospital IVF Unit
Key inclusion criteria (3 listed)
- Age < 40 years
- Basal FSH < 12 IU/L
- Basal P < 1.6 ng/mL
Key exclusion criteria (3 listed)
- Women with polycystic ovaries syndrome (PCOS)
- Women with Stage III-IV Endometriosis
- Women with a pathological condition of the adrenal glands
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 |
|---|---|---|
| Serum Progesterone Levels | Other | Serum Progesteron Levels |
Primary outcome
Clinical pregnancy
Time frame: At 6-8 weeks of gestation
Clinical pregnancy, defined as ultrasound evidence of gestational sac at 6 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
Turgut Aydin principal investigator
Acıbadem Kayseri Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Assisted Reproductive Technology, run by Acibadem University.
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 3 inclusion and 3 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 10 Apr 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?
Results are not available in the source record.
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: At 6-8 weeks of gestation). 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 10 Apr 2014.