The Role of ICSI in Non-male Factor Infertility in Advanced Maternal Age
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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.
    

Detailed description: 
      ICSI is a method used in IVF in which a single sperm is injected directly into an oocyte.
      Originally ICSI was developed as a method for the treatment for couples with severe male
      factor infertility. In the last decades the use of ICSI has increased dramatically,
      especially for non-male factor infertility. In certain fertility clinics in the world ICSI is
      conducted in 100% of IVF cycles.

      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.
    

Intervention name(s): ICSI; Conventional IVF
Intervention type(s): Other; Other
Intervention description(s): Oocytes retrieved from one ovary will undergo insemination by ICSI.; Oocytes retrieved from the second ovary will undergo insemination by conventional IVF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ICSI; IVF; Infertility; non-male factor; intracytoplasmic sperm injection; In vitro fertilization