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

August 29, 2011 updated by: Bollmann Bruckner Noss

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80331
        • Praxis Bollmann-Brückner-Noss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • missing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 13 weeks
Patients will be followed up from embryotransfer until second trimester of pregnancy
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery after 23.gestational weeks
Time Frame: 9 months
Patients will be followed up from embryotransfer until delivery
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bollmann Bruckner Noss

Investigators

  • Principal Investigator: Robert Ochsenkuehn, MD, Center for Reproductive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 28, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prog2006-2011
  • BBN (Other Identifier: Center for Reproductive Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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