Identification of Viable Human Embryos Using Three Different Methods

NCT01139268 | Completed DMC

• 1 other identifier: M-20090241
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 2

Brief Summary

Infertility affects an increasing number of couples. For many, the choice of treatment is in vitro fertilization (IVF) . Currently, there are no markers fully predictive of developmental competence of IVF embryos. Present embryo selection is based on morphology assessment, which produces implantation rates in the range of 20%-30 %. The overall purpose of the present study is to investigate methods for selection of the best embryo. We aim to examine the relationship between pregnancy outcome and the transcriptional profile of selected genes, cleavage kinetics (time-lapse), and metabolic profile. We hypothesise that the quality of the embryo is reflected by the transcription of selected genes, the cleavage kinetics, and the metabolic profile. If so, these parameters can predict the success or failure of a pregnancy. Furthermore, the interrelationship - if any - between these parameters will be evaluated. A secondary aim is to evaluate the effect of blastomere biopsy using time-lapse and metabolic analysis

Conditions

Infertility

Keywords

embryo viability

Outcome Measures

Primary Outcomes (1)

• implantation/clinical pregnancy confirmed with pregnancy test and ultrasound

  measurement of urine-hCG and vaginal ultrasound scan to evaluate pregnant/not pregnant

  8 weeks after embryo transfer

Secondary Outcomes (3)

• gene expression quantified with Q-PCR

  within 6 months after biopsy and embryo transfer

• Metabolic profile using NIR analysis

  within 6 months after collection

• cleavage kinetics

  before embryo transfer, during culturing

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing ART treament with single embryo transfer at the Fertility clinic, Aarhus University hospital Skejby, due to infertility,

You may qualify if:

• age \< 38 years
• \> 8 retrieved oocytes in present cycle or \> 6 fertilized.

You may not qualify if:

• endometriosis

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

The Fertility Clinic, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Fertility Clinic, Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (5)

• Kirkegaard K, Svane AS, Nielsen JS, Hindkjaer JJ, Nielsen NC, Ingerslev HJ. Nuclear magnetic resonance metabolomic profiling of Day 3 and 5 embryo culture medium does not predict pregnancy outcome in good prognosis patients: a prospective cohort study on single transferred embryos. Hum Reprod. 2014 Nov;29(11):2413-20. doi: 10.1093/humrep/deu236. Epub 2014 Sep 24.

  PMID: 25256566 DERIVED

• Sundvall L, Ingerslev HJ, Breth Knudsen U, Kirkegaard K. Inter- and intra-observer variability of time-lapse annotations. Hum Reprod. 2013 Dec;28(12):3215-21. doi: 10.1093/humrep/det366. Epub 2013 Sep 26.

  PMID: 24070998 DERIVED

• Kirkegaard K, Hindkjaer JJ, Ingerslev HJ. Hatching of in vitro fertilized human embryos is influenced by fertilization method. Fertil Steril. 2013 Nov;100(5):1277-82. doi: 10.1016/j.fertnstert.2013.07.005. Epub 2013 Jul 30.

  PMID: 23909991 DERIVED

• Kirkegaard K, Kesmodel US, Hindkjaer JJ, Ingerslev HJ. Time-lapse parameters as predictors of blastocyst development and pregnancy outcome in embryos from good prognosis patients: a prospective cohort study. Hum Reprod. 2013 Oct;28(10):2643-51. doi: 10.1093/humrep/det300. Epub 2013 Jul 30.

  PMID: 23900207 DERIVED

• Kirkegaard K, Hindkjaer JJ, Ingerslev HJ. Effect of oxygen concentration on human embryo development evaluated by time-lapse monitoring. Fertil Steril. 2013 Mar 1;99(3):738-744.e4. doi: 10.1016/j.fertnstert.2012.11.028. Epub 2012 Dec 11.

  PMID: 23245683 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

biopsies from human embryos

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jakob Ingerslev, MD, DMsc

  Fertility Clinic, Aarhus University Hospital, Skejby

  STUDY DIRECTOR

• kirstine Kirkegaard, MD

  Fertility Clinic, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

• Johnny Hindkjær, DM.Sc.

  Fertility Clinic, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

• Birte Degn, DmSc. PhD

  Fertility Clinic, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

• Karin Lykke-Hartmann, DmSc, PhD

  Aarhus University, Department of Medical Biochemistry

  PRINCIPAL INVESTIGATOR

• Steen Koelvraa, MD, DMSc

  Department of Clinical Genetics, Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

DK (2)