Culture Media and Blastocyst Development

NCT03497052 | Unknown

• 1 other identifier: CVG11112017
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this non-interventional study is to compare the blastulation rate per fertilized oocyte in two different single step culture media commercially available (GEMS and Irvine culture media).

Conditions

Embryo Development

Keywords

IVF culture media; Blastocyst; Time-lapse microscopy

Outcome Measures

Primary Outcomes (1)

• Blastulation rate

  The number of embryos reaching the blastocyst stage (day-5, day-6 or day-7 of preimplantation development) per fertilized oocyte (2PN)

  7 days

Study Arms (2)

Group 1

Oocytes and embryos will be cultured in GEMS single step medium (in vitro culture in medium 1)

Other: In vitro culture in medium 1

Group 2

Oocytes and embryos will be cultured in IRVINE single step medium (in vitro culture in medium 2)

Other: In vitro culture in medium 2

Interventions

In vitro culture in medium 1 OTHER

Oocytes and embryos will be cultured in GEMS media (single step media) up to blastocyst stage.Standard IVF culture will be performed in a time lapse incubator. No drugs will be used.

Group 1

In vitro culture in medium 2 OTHER

Oocytes will be cultured in IRVINE media (single step media) up to blastocyst stage.Standard IVF culture will be performed in a time lapse incubator. No drugs will be used.

Group 2

Eligibility Criteria

• Age: Up to 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Assuming an overall blastulation rate of 34% a minimal relevant difference of 7% corresponds to an odds ratio of blastulation of 1.4. In order to detect with alfa=5% (2-sided) and power = 80% an odds ratio of 1.4, approximately 1200 (1182) oocytes need to be included (Hulley et al., 2013) split in 2 groups of equal sizes, that correspond approximately to 160 - 200 women (aprox. 6 oocytes/woman retrieved and considering a fertilization rate 80%).

You may qualify if:

• Woman not older than 42 years of age, presenting between 4 and 8 normal appearing MII oocytes and undergoing ICSI treatment with ejaculated sperm

You may not qualify if:

• Men with surgically extracted spermatozoa and very severe oligoastenoteratozoospermia (motile sperm count \<500.000/ml after preparation)
• Oocytes coming from patients enrolled in PGT-M (preimplantation genetic testing for monogenic diseases) and PGT-SR (preimplantation genetic testing for structural chromosomal abnormalities) programs.

Sponsors & Collaborators

• Clinica Valle Giulia: lead

Study Sites (1)

Clinica Valle Giulia

Roma, 00197, Italy

RECRUITING

Related Publications (15)

• Biggers JD, Summers MC. Choosing a culture medium: making informed choices. Fertil Steril. 2008 Sep;90(3):473-83. doi: 10.1016/j.fertnstert.2008.08.010.

  PMID: 18847602 BACKGROUND

• Gardner DK, Lane M. Culture and selection of viable blastocysts: a feasible proposition for human IVF? Hum Reprod Update. 1997 Jul-Aug;3(4):367-82. doi: 10.1093/humupd/3.4.367.

  PMID: 9459282 BACKGROUND

• 3. Gardner D, Schoolcraft W. In vitro culture of the human blastocyst. In: Jansen R, Mortimer D, editors. Towards reproductive certainty: infertility and genetics beyond 1999. Carnforth, UK: Parthenon Publishing; 1999. p. 378-88

  BACKGROUND

• Gardner DK, Lane M, Calderon I, Leeton J. Environment of the preimplantation human embryo in vivo: metabolite analysis of oviduct and uterine fluids and metabolism of cumulus cells. Fertil Steril. 1996 Feb;65(2):349-53. doi: 10.1016/s0015-0282(16)58097-2.

  PMID: 8566260 BACKGROUND

• Gardner DK, Lane M. Culture of viable human blastocysts in defined sequential serum-free media. Hum Reprod. 1998 Jun;13 Suppl 3:148-59; discussion 160. doi: 10.1093/humrep/13.suppl_3.148.

  PMID: 9755421 BACKGROUND

• Glujovsky D, Farquhar C, Quinteiro Retamar AM, Alvarez Sedo CR, Blake D. Cleavage stage versus blastocyst stage embryo transfer in assisted reproductive technology. Cochrane Database Syst Rev. 2016 Jun 30;(6):CD002118. doi: 10.1002/14651858.CD002118.pub5.

  PMID: 27357126 BACKGROUND

• Machtinger R, Racowsky C. Culture systems: single step. Methods Mol Biol. 2012;912:199-209. doi: 10.1007/978-1-61779-971-6_12.

  PMID: 22829376 BACKGROUND

• Martins WP, Nastri CO, Rienzi L, van der Poel SZ, Gracia CR, Racowsky C. Obstetrical and perinatal outcomes following blastocyst transfer compared to cleavage transfer: a systematic review and meta-analysis. Hum Reprod. 2016 Nov;31(11):2561-2569. doi: 10.1093/humrep/dew244. Epub 2016 Oct 7.

  PMID: 27907898 BACKGROUND

• Martins WP, Nastri CO, Rienzi L, van der Poel SZ, Gracia C, Racowsky C. Blastocyst vs cleavage-stage embryo transfer: systematic review and meta-analysis of reproductive outcomes. Ultrasound Obstet Gynecol. 2017 May;49(5):583-591. doi: 10.1002/uog.17327. Epub 2017 Apr 10.

  PMID: 27731533 BACKGROUND

• Rienzi L, Ubaldi FM, Iacobelli M, Minasi MG, Romano S, Ferrero S, Sapienza F, Baroni E, Litwicka K, Greco E. Significance of metaphase II human oocyte morphology on ICSI outcome. Fertil Steril. 2008 Nov;90(5):1692-700. doi: 10.1016/j.fertnstert.2007.09.024. Epub 2008 Feb 4.

  PMID: 18249393 BACKGROUND

• Ubaldi FM, Capalbo A, Colamaria S, Ferrero S, Maggiulli R, Vajta G, Sapienza F, Cimadomo D, Giuliani M, Gravotta E, Vaiarelli A, Rienzi L. Reduction of multiple pregnancies in the advanced maternal age population after implementation of an elective single embryo transfer policy coupled with enhanced embryo selection: pre- and post-intervention study. Hum Reprod. 2015 Sep;30(9):2097-106. doi: 10.1093/humrep/dev159. Epub 2015 Jul 5.

  PMID: 26150408 BACKGROUND

• Quinn P. Culture systems: sequential. Methods Mol Biol. 2012;912:211-30. doi: 10.1007/978-1-61779-971-6_13.

  PMID: 22829377 BACKGROUND

• Sfontouris IA, Martins WP, Nastri CO, Viana IG, Navarro PA, Raine-Fenning N, van der Poel S, Rienzi L, Racowsky C. Blastocyst culture using single versus sequential media in clinical IVF: a systematic review and meta-analysis of randomized controlled trials. J Assist Reprod Genet. 2016 Oct;33(10):1261-1272. doi: 10.1007/s10815-016-0774-5. Epub 2016 Aug 5.

  PMID: 27491772 BACKGROUND

• Summers MC, Biggers JD. Chemically defined media and the culture of mammalian preimplantation embryos: historical perspective and current issues. Hum Reprod Update. 2003 Nov-Dec;9(6):557-82. doi: 10.1093/humupd/dmg039.

  PMID: 14714592 BACKGROUND

• 15. Hulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing clinical research: an epidemiologic approach. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2013. Appendix 6B, page 75

  BACKGROUND

Study Officials

• Laura Rienzi, MSc

  Clinica Valle Giulia, G.en.e.r.a. centers for reproductive medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Rienzi, MSc

CONTACT

+39063269791; rienzi@generaroma.it

Danilo Cimadomo, PhD

CONTACT

+393470182967; cimadomo@generaroma.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

IT (1)