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Progesterone on the Day of Ovulation Induction is Associated With Pregnancy Outcome (ProgBBN)

This study has been completed.
Sponsor:
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
History of Changes
  Purpose

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.


Condition
Female Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Progesterone Levels on the Day of Ovulation Induction and IVF Outcome: Retrospective Study With 2500 Controlled Ovarian Stimulations Cycles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bollmann Bruckner Noss:

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Patients will be followed up from embryotransfer until second trimester of pregnancy


Secondary Outcome Measures:
  • Delivery after 23.gestational weeks [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Patients will be followed up from embryotransfer until delivery


Enrollment: 2555
Study Start Date: January 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Female patients with infertility undergoing assisted reproduction techniques, i.e. in vitro fertilization.

Criteria

Inclusion Criteria:

  • IVF/ICSI following controlled ovarian stimulation
  • progesterone measured on the day of ovulation induction
  • informed consent

Exclusion Criteria:

  • missing consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426152

Locations
Germany
Praxis Bollmann-Brückner-Noss
Munich, Bavaria, Germany, 80331
Sponsors and Collaborators
Bollmann Bruckner Noss
Investigators
Principal Investigator: Robert Ochsenkuehn, MD Center for Reproductive Medicine
  More Information

No publications provided by Bollmann Bruckner Noss

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bollmann Bruckner Noss
ClinicalTrials.gov Identifier: NCT01426152     History of Changes
Other Study ID Numbers: Prog2006-2011, BBN
Study First Received: August 28, 2011
Last Updated: August 29, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Bollmann Bruckner Noss:
IVF
progesterone
ovulation induction
pregnancy rates
Female Infertility Due to Nonimplantation

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013