The Role of ICSI in Non-male Factor Infertility in Advanced Maternal Age
NCT ID: NCT03370068
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2018-01-01
2020-07-01
Brief Summary
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Detailed Description
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Despite the increased use of ICSI, there is no clear evidence that ICIS is more effective than conventional IVF for non-male factor infertility. There are currently few randomized controlled studies that compared the two modalities in the case of non-male factor infertility. In a randomized controlled trial that included 415 couples with non-male factor infertility and women younger than 37 years of age, conventional IVF was associated with better fertilization and implantation rates than ICSI but with comparable live birth rates. In addition, studies have not shown an advantage for ICSI over conventional IVF in the case of unexplained infertility, low oocyte yield or routine use to decrease the incidence of fertilization failure.
The proportion of women after the age of 35 undergoing IVF is constantly on the rise. Oocytes retrieved from older women are often of lower quality then oocytes retrieved from younger women. It is believed that due to the lower quality the fertilization rate is decreased in this population. However a recently published retrospective study including 745 women did not show an advantage for ICSI over conventional IVF. Contrary to what is believed, the conventional IVF group had a higher number of zygotes formed, more cycles with embryos transferred at the blastocyst stage and more cycles where embryos were available for cryopreservation.
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. Male-factor infertility will be diagnosed according to the accepted semen analysis values included a semen concentration of 200 million/mL, progressive motility of 40% and a strict morphology of 4%. Patients will undergo standard clinical and hormonal investigation as usual for IVF. The treatment protocol will be in accordance with the decision of the attending physician, regardless of the research. Randomization will be between the ovaries of each patient. Following an informed consent a computer based randomization will allocate either ICSI or conventional IVF for each ovary so that for each study participant oocyte from one ovary will be randomly allocated to insemination by ICSI and the oocytes from the other ovary will be allocated to insemination by conventional IVF. As is customary in our IVF unit, 24, 72 and 96 hours after oocyte retrieval, the embryos will by studied by an embryologist for the number of cells and embryo quality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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ICSI
All the oocytes in this group (from one ovary) will undergo insemination by ICSI.
ICSI
Oocytes retrieved from one ovary will undergo insemination by ICSI.
Conventional IVF
All the oocytes in this group (from the other ovary) will undergo insemination by conventional IVF.
Conventional IVF
Oocytes retrieved from the second ovary will undergo insemination by conventional IVF
Interventions
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ICSI
Oocytes retrieved from one ovary will undergo insemination by ICSI.
Conventional IVF
Oocytes retrieved from the second ovary will undergo insemination by conventional IVF
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
39 Years
44 Years
FEMALE
Yes
Sponsors
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Dr. Tal Miller-Elkan
OTHER_GOV
Responsible Party
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Dr. Tal Miller-Elkan
Principal Investigator
Principal Investigators
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Tal TE Elkan Miller, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Cente
Locations
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IVF Unit, Sheba medical Center
Tel Litwinsky, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SHEBA-17-4531-TEM-CTIL
Identifier Type: -
Identifier Source: org_study_id
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