NCT01426152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,555

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

5.2 years

First QC Date

August 28, 2011

Last Update Submit

August 29, 2011

Conditions

Keywords

IVFprogesteroneovulation inductionpregnancy ratesFemale Infertility Due to Nonimplantation

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Patients will be followed up from embryotransfer until second trimester of pregnancy

    13 weeks

Secondary Outcomes (1)

  • Delivery after 23.gestational weeks

    9 months

Study Arms (3)

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • missing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis Bollmann-Brückner-Noss

Munich, Bavaria, 80331, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Robert Ochsenkuehn, MD

    Center for Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2011

First Posted

August 31, 2011

Study Start

January 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 31, 2011

Record last verified: 2011-08

Locations