NCT03370068

Brief Summary

The use of Intracytoplasmic sperm injection (ICSI) has increased in the last decades regardless of the cause of infertility. Despite the increased use there is no clear evidence that ICIS is more effective than conventional in vitro fertilization (IVF) for non-male factor infertility. The investigators therefore aim to perform a prospective randomized controlled study to compare between ICSI and conventional IVF in women between 39 to 44 years of age with non-male factor infertility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

November 20, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

November 20, 2017

Last Update Submit

July 26, 2020

Conditions

Infertility, Female

Keywords

ICSIIVFInfertilitynon-male factorintracytoplasmic sperm injectionIn vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    The rate of fertilized oocytes

    1 day

Secondary Outcomes (5)

  • Embryos

    3-4 day

  • Top quality embryos

    3-4 days

  • Pregnancy

    Approximately 2 weeks

  • Clinical pregnancy

    Approximately 6 weeks

  • Pregnancy above 8 weeks gestation

    Approximately 8 weeks

Study Arms (2)

ICSI

EXPERIMENTAL

All the oocytes in this group (from one ovary) will undergo insemination by ICSI.

Other: ICSI

Conventional IVF

ACTIVE COMPARATOR

All the oocytes in this group (from the other ovary) will undergo insemination by conventional IVF.

Other: Conventional IVF

Interventions

ICSIOTHER

Oocytes retrieved from one ovary will undergo insemination by ICSI.

ICSI
Conventional IVFOTHER

Oocytes retrieved from the second ovary will undergo insemination by conventional IVF

Conventional IVF

Eligibility Criteria

Age39 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 39 to 44 years of age undergoing IVF treatments for non-male factor infertility.

You may not qualify if:

  • Women undergoing IVF treatments for male factor infertility.
  • Cases where PGD is planned.
  • Women with a BMI above 40.
  • Women younger then 39 years of age or older then 44 years of age.
  • Women with a rate of fertilization bellow 50% in previous IVF cycles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Unit, Sheba medical Center

Tel Litwinsky, Israel

Location

Related Publications (9)

  • Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.

    PMID: 1351601BACKGROUND

  • Boulet SL, Mehta A, Kissin DM, Warner L, Kawwass JF, Jamieson DJ. Trends in use of and reproductive outcomes associated with intracytoplasmic sperm injection. JAMA. 2015 Jan 20;313(3):255-63. doi: 10.1001/jama.2014.17985.

    PMID: 25602996BACKGROUND

  • Bhattacharya S, Hamilton MP, Shaaban M, Khalaf Y, Seddler M, Ghobara T, Braude P, Kennedy R, Rutherford A, Hartshorne G, Templeton A. Conventional in-vitro fertilisation versus intracytoplasmic sperm injection for the treatment of non-male-factor infertility: a randomised controlled trial. Lancet. 2001 Jun 30;357(9274):2075-9. doi: 10.1016/s0140-6736(00)05179-5.

    PMID: 11445099BACKGROUND

  • Check JH, Yuan W, Garberi-Levito MC, Swenson K, McMonagle K. Effect of method of oocyte fertilization on fertilization, pregnancy and implantation rates in women with unexplained infertility. Clin Exp Obstet Gynecol. 2011;38(3):203-5.

    PMID: 21995144BACKGROUND

  • Luna M, Bigelow C, Duke M, Ruman J, Sandler B, Grunfeld L, Copperman AB. Should ICSI be recommended routinely in patients with four or fewer oocytes retrieved? J Assist Reprod Genet. 2011 Sep;28(10):911-5. doi: 10.1007/s10815-011-9614-9. Epub 2011 Jul 27.

    PMID: 21792665BACKGROUND

  • Fishel S, Aslam I, Lisi F, Rinaldi L, Timson J, Jacobson M, Gobetz L, Green S, Campbell A, Lisi R. Should ICSI be the treatment of choice for all cases of in-vitro conception? Hum Reprod. 2000 Jun;15(6):1278-83. doi: 10.1093/humrep/15.6.1278.

    PMID: 10831555BACKGROUND

  • Korkmaz C, Tekin YB, Sakinci M, Ercan CM. Effects of maternal ageing on ICSI outcomes and embryo development in relation to oocytes morphological characteristics of birefringent structures. Zygote. 2015 Aug;23(4):550-5. doi: 10.1017/S0967199414000197. Epub 2014 May 29.

    PMID: 24869767BACKGROUND

  • Tannus S, Son WY, Gilman A, Younes G, Shavit T, Dahan MH. The role of intracytoplasmic sperm injection in non-male factor infertility in advanced maternal age. Hum Reprod. 2017 Jan;32(1):119-124. doi: 10.1093/humrep/dew298. Epub 2016 Nov 16.

    PMID: 27852688BACKGROUND

  • Haas J, Miller TE, Nahum R, Aizer A, Kirshenbaum M, Zilberberg E, Lebovitz O, Orvieto R. The role of ICSI vs. conventional IVF for patients with advanced maternal age-a randomized controlled trial. J Assist Reprod Genet. 2021 Jan;38(1):95-100. doi: 10.1007/s10815-020-01990-5. Epub 2020 Oct 28.

    PMID: 33118102DERIVED

MeSH Terms

Conditions

Infertility, FemaleInfertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Tal TE Elkan Miller, MD PhD

    Sheba Medical Cente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 12, 2017

Study Start

January 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)