The Influence of Polycystic Ovairan Syndrome on Embryonic Developmental Timing
PCOS
Timing of Development in Embryos Derived From Women With Polycystic Ovairan Syndrome and Controls
1 other identifier
observational
240
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Shorter than P25 for all trials
1 active site
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
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedSeptember 30, 2013
September 1, 2013
1 year
September 23, 2013
September 25, 2013
Conditions
Keywords
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
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
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.
PMID: 25925351DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ulla B Knudsen, Professor
Fertility Clinic Aarhus University
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