SubfertilityPROG2NCT01067664
Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome
An observational study of Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Subfertility
- How many people
- 130 participants
- Where
- 1 siteGreece
- Study dates
- May 2009to Jun 2013
- 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
- No healthy volunteers
- Adult
Study population: Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro fertilization.
Who may be able to join
- Age < 40 years
- Basal FSH < 12 IU/L
- Basal P < 1.6 ng/mL
Who cannot join
- Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation)
- Women with polycystic ovaries syndrome (PCOS)
- Women with Stage III-IV Endometriosis
- Women with a pathological condition of the adrenal glands
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki
About this study
Official title: The Effect of Serum Progesterone Levels on the Day of hCG Administration on the Probability of Pregnancy in Patients Treated by IVF Using GnRH Antagonists and Recombinant Gonadotrophins
This observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins.
There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF.
This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.
- Conditions
- Subfertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing IVF with rFSH and GnRH antagonists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation
Measured: At 6-8 weeks of gestation
Secondary outcomes (1)
Pregnancy (defined as a b-hCG> 25 IU/L)
Measured: 12 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Basil C Tarlatzis, MD, PhD, Principal investigator, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of ThessalonikiChristos A Venetis, MD, MSc, Principal investigator, Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067664
- Sponsor's protocol ID
- UHR-7
- Acronym
- PROG2
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 2009
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serum Progesterone Levels on the Day of hCG Administration on the Probability of Pregnancy in Patients Treated by IVF Using GnRH Antagonists and Recombinant Gonadotrophins
- ClinicalTrials.gov ID
- NCT01067664
- Acronym / sponsor ID
- PROG2 / UHR-7
- Conditions
- Subfertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Feb 2010 (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 attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins.
There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF.
This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing IVF with rFSH and GnRH antagonists | – | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro fertilization.
Key inclusion criteria (3 listed)
- Age < 40 years
- Basal FSH < 12 IU/L
- Basal P < 1.6 ng/mL
Key exclusion criteria (4 listed)
- Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation)
- 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.
Primary outcome
Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation
Time frame: At 6-8 weeks of gestation
1 secondary outcome
Pregnancy (defined as a b-hCG> 25 IU/L)
Time frame: 12 days after embryo transfer
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 18 Oct 2013.
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The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
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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.
Basil C Tarlatzis, MD, PhD principal investigator
1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Christos A Venetis, MD, MSc principal investigator
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
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 Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 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 18 Oct 2013. 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 Greece. 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?
Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation (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 18 Oct 2013.