NCT01953146

Brief Summary

Polycystic ovary syndrome is one of the most common causes of female infertility. The cause of infertility in PCOS is unknown. Factors other than anovulation, including inherited or induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo development is a sensitive method of detecting reduced embryo viability. Yet, there are no data regarding the embryo development in PCOS assessed by time-lapse analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

September 23, 2013

Last Update Submit

September 25, 2013

Conditions

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

  • Embryonic developmental timing assessed by Time-lapse analysis

    Embryos were cultured in a time-lapse incubator until arrest or removal at day 6. The time-point of an event was annotated and analyzed for the embryos in focus (in order of appearance).The influence of PCOS on embryo developmental timing was tested in regression models for patient-clustered data

    From fertilization until transfer at day 6

Study Arms (1)

PCOS criteria

nfertile patients undergoing assisted reproduction were consecutively recruited at the Fertility Clinic, Arhus University Hospital from February 2011 to May 2013. Women aged \< 38 years without endometriosis where more than \> 8 oocytes were retrieved were eligible. Patients were categorized in PCOS and non-PCOS according to the Rotterdam criteria for PCOS, defined by the presence of anovulation and polycystic ovaries.

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A consecutive cohort of 249 infertile women attending In vitro fertilization (IVF) or Intra-cytoplasmic sperm injection (ICSI) treatment at the Fertility Clinic, Arhus University Hospital from February 2011 to May 2013.

You may qualify if:

  • Women aged \< 38 years without endometriosis and with more than \> 8 oocytes retrieved were eligible. -

You may not qualify if:

  • All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic

Aarhus, N, 8200, Denmark

Location

Related Publications (1)

  • Sundvall L, Kirkegaard K, Ingerslev HJ, Knudsen UB. Unaltered timing of embryo development in women with polycystic ovarian syndrome (PCOS): a time-lapse study. J Assist Reprod Genet. 2015 Jul;32(7):1031-42. doi: 10.1007/s10815-015-0488-0. Epub 2015 May 1.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ulla B Knudsen, Professor

    Fertility Clinic Aarhus University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 30, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations