Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome (ProgBBN)
This study has been completed.
Sponsor:
Bollmann Bruckner Noss
Information provided by (Responsible Party):
Bollmann Bruckner Noss
ClinicalTrials.gov Identifier:
NCT01426152
First received: August 28, 2011
Last updated: August 29, 2011
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | August 28, 2011 | ||||
| Last Updated Date | August 29, 2011 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ongoing pregnancy rate [ Time Frame: 13 weeks ] [ Designated as safety issue: No ] Patients will be followed up from embryotransfer until second trimester of pregnancy |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01426152 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Delivery after 23.gestational weeks [ Time Frame: 9 months ] [ Designated as safety issue: No ] Patients will be followed up from embryotransfer until delivery |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome | ||||
| Official Title ICMJE | Association Between Progesterone Levels on the Day of Ovulation Induction and IVF Outcome: Retrospective Study With 2500 Controlled Ovarian Stimulations Cycles | ||||
| Brief 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. The hypothesis is that higher progesterone levels are associated with lower implantation rates due to changes in the endometrial receptivity. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Female patients with infertility undergoing assisted reproduction techniques, i.e. in vitro fertilization. |
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| Condition ICMJE | Female Infertility | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Ochsenkühn R, Arzberger A, von Schönfeldt 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. Epub 2012 May 24. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2555 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01426152 | ||||
| Other Study ID Numbers ICMJE | Prog2006-2011, BBN | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Bollmann Bruckner Noss | ||||
| Study Sponsor ICMJE | Bollmann Bruckner Noss | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bollmann Bruckner Noss | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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