PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer (PILOT STUDY)

NCT03764865 | Completed

• 1 other identifier: 2018P000530
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this small-scale pilot study (10 patients) is to test the study protocol for an RCT comparing IVF outcomes between day 3 and day 5 embryo transfer in patients with five or fewer embryos in a fresh embryo transfer in vitro fertilization (IVF) cycle. Information derived from this RCT would allow us to maximize the chances of success for these patients undergoing IVF.

Conditions

Infertility

Keywords

cleavage embryo; blastocyst; embryo transfer; in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• live birth

  defined as delivery of a live born infant ≥22 weeks of gestation

  9 months

Secondary Outcomes (4)

• Clinical pregnancy

  14 days

• Ongoing pregnancy

  9 months

• Multiple pregnancy

  9 months

• Time to pregnancy/live birth

  2 years

Study Arms (2)

day 3 embryo transfer

EXPERIMENTAL

embryo transfer 3 days after fertilization

Procedure: day 3 uterine transfer

day 5 embryo transfer

EXPERIMENTAL

embryo transfer 5 days after fertilization

Procedure: day 5 uterine transfer

Interventions

day 3 uterine transfer PROCEDURE

uterine transfer of embryo on day 3 after fertilization (cleavage stage)

day 3 embryo transfer

day 5 uterine transfer PROCEDURE

uterine transfer of embryo on day 5 after fertilization (blastocyst stage)

day 5 embryo transfer

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First autologous IVF cycle
• Written, informed consent

You may not qualify if:

• Planned gestational carrier
• Planned donor egg
• Morbid obesity: BMI \>40
• History of recurrent pregnancy loss (≥2 spontaneous abortions)
• Presence of uterine factor infertility
• Treatment plan includes embryos cultured 'out of protocol'
• Planned preimplantation genetic testing

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston IVF: collaborator

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (8)

• Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Blastocyst culture and transfer in clinical-assisted reproduction: a committee opinion. Fertil Steril. 2013 Mar 1;99(3):667-72. doi: 10.1016/j.fertnstert.2013.01.087.

  PMID: 23714439 BACKGROUND

• Gardner DK, Schoolcraft WB, Wagley L, Schlenker T, Stevens J, Hesla J. A prospective randomized trial of blastocyst culture and transfer in in-vitro fertilization. Hum Reprod. 1998 Dec;13(12):3434-40. doi: 10.1093/humrep/13.12.3434.

  PMID: 9886530 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

• Papanikolaou EG, D'haeseleer E, Verheyen G, Van de Velde H, Camus M, Van Steirteghem A, Devroey P, Tournaye H. Live birth rate is significantly higher after blastocyst transfer than after cleavage-stage embryo transfer when at least four embryos are available on day 3 of embryo culture. A randomized prospective study. Hum Reprod. 2005 Nov;20(11):3198-203. doi: 10.1093/humrep/dei217. Epub 2005 Jul 29.

  PMID: 16055454 BACKGROUND

• Papanikolaou EG, Camus M, Kolibianakis EM, Van Landuyt L, Van Steirteghem A, Devroey P. In vitro fertilization with single blastocyst-stage versus single cleavage-stage embryos. N Engl J Med. 2006 Mar 16;354(11):1139-46. doi: 10.1056/NEJMoa053524.

  PMID: 16540614 BACKGROUND

• Marek D, Langley M, Gardner DK, Confer N, Doody KM, Doody KJ. Introduction of blastocyst culture and transfer for all patients in an in vitro fertilization program. Fertil Steril. 1999 Dec;72(6):1035-40. doi: 10.1016/s0015-0282(99)00409-4.

  PMID: 10593377 BACKGROUND

• Tsirigotis M. Blastocyst stage transfer: pitfalls and benefits. Too soon to abandon current practice? Hum Reprod. 1998 Dec;13(12):3285-9. doi: 10.1093/humrep/13.12.3285. No abstract available.

  PMID: 9886498 BACKGROUND

• Neuhausser WM, Vaughan DA, Sakkas D, Hacker MR, Toth T, Penzias A. Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial. Reprod Health. 2020 Jan 30;17(1):16. doi: 10.1186/s12978-020-0870-y.

  PMID: 32000803 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Werner Neuhausser, MD PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics, Gynecology and Reproductive Biology

Model Details: non-inferiority

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)