Female InfertilityProgBBNNCT01426152
Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome
An observational study of Female Infertility, run by Bollmann Bruckner Noss at 1 site in Germany.
Trial summary
Progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Infertility
- How many people
- 2,555 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Apr 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with infertility undergoing assisted reproduction techniques, i.e. in vitro fertilization.
Who may be able to join
- IVF/ICSI following controlled ovarian stimulation
- progesterone measured on the day of ovulation induction
- informed consent
Who cannot join
- missing consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Progesterone Levels on the Day of Ovulation Induction and IVF Outcome: Retrospective Study With 2500 Controlled Ovarian Stimulations Cycles
Progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. The hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity.
- Conditions
- Female Infertility
- Keywords
- IVF, progesterone, ovulation induction, pregnancy rates, Female Infertility Due to Nonimplantation
- Medical subject headings
- Infertility, Female
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 |
|---|---|---|
| Low level progesterone group (1) | Progesterone < 1.50 ng/mL on day of ovulation induction | |
| Medium level progesterone group (2) | Progesterone 1.51-1.99 ng/mL on the day of ovulation induction | |
| High level progesterone group (3) | Progesterone > 1.99 ng/mL on the day of ovulation induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Patients will be followed up from embryotransfer until second trimester of pregnancy
Measured: 13 weeks
Secondary outcomes (1)
Delivery after 23.gestational weeks
Patients will be followed up from embryotransfer until delivery
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startJan 2006
- Primary completionApr 2011
- Study completionApr 2011
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 Female 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
- Retrospective
- Enrolment
- 2,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bollmann Bruckner Noss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Ochsenkuehn, MD, Principal investigator, Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426152
- Sponsor's protocol ID
- Prog2006-2011
- Other IDs
- BBN
- Acronym
- ProgBBN
- Status last verified
- Aug 2011
- First submitted
- 28 Aug 2011
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ochsenkuhn R, Arzberger A, von Schonfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.
PubMed 22633265
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Progesterone Levels on the Day of Ovulation Induction and IVF Outcome: Retrospective Study With 2500 Controlled Ovarian Stimulations Cycles
- ClinicalTrials.gov ID
- NCT01426152
- Acronym / sponsor ID
- ProgBBN / Prog2006-2011
- Conditions
- Female Infertility
- Keywords
- IVF, progesterone, ovulation induction, pregnancy rates, Female Infertility Due to Nonimplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,555 participants (actual)
- Lead sponsor
- Bollmann Bruckner NossUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 31 Aug 2011 (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.
Progesterone levels measured in blood/serum of patients on the day of ovulation induction following controlled ovarian stimulation for in vitro fertilization may be associated with pregnancy outcome. The hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level progesterone group (1) | – | –Progesterone < 1.50 ng/mL on day of ovulation induction |
| Medium level progesterone group (2) | – | –Progesterone 1.51-1.99 ng/mL on the day of ovulation induction |
| High level progesterone group (3) | – | –Progesterone > 1.99 ng/mL on the day of ovulation induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with infertility undergoing assisted reproduction techniques, i.e. in vitro fertilization.
Key inclusion criteria (3 listed)
- IVF/ICSI following controlled ovarian stimulation
- progesterone measured on the day of ovulation induction
- informed consent
Key exclusion criteria (1 listed)
- missing consent
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
Ongoing pregnancy rate
Time frame: 13 weeks
Patients will be followed up from embryotransfer until second trimester of pregnancy
1 secondary outcome
Delivery after 23.gestational weeks
Time frame: 9 months
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 31 Aug 2011.
- Derived from this study: PubMed 22633265Ochsenkuhn R, Arzberger A, von Schonfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.
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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.
Robert Ochsenkuehn, MD principal investigator
Center for Reproductive Medicine
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 Female Infertility, run by Bollmann Bruckner Noss at 1 site in Germany.
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 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 31 Aug 2011. 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 Germany. 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?
Ongoing pregnancy rate (time frame: 13 weeks). 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 NCT01426152, 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 31 Aug 2011.