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Trial record 22 of 1991 for:    infertility AND (woman OR women OR female)

The Role of ICSI in Non-male Factor Infertility in Advanced Maternal Age (ICSI)

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ClinicalTrials.gov Identifier: NCT03370068
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Tal Miller-Elkan, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Other: ICSI Other: Conventional IVF Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Role of Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Maternal Age Above 39
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ICSI
All the oocytes in this group (from one ovary) will undergo insemination by ICSI.
Other: ICSI
Oocytes retrieved from one ovary will undergo insemination by ICSI.

Active Comparator: Conventional IVF
All the oocytes in this group (from the other ovary) will undergo insemination by conventional IVF.
Other: Conventional IVF
Oocytes retrieved from the second ovary will undergo insemination by conventional IVF




Primary Outcome Measures :
  1. Fertilization [ Time Frame: 1 day ]
    The number of fertilized oocytes


Secondary Outcome Measures :
  1. Embryos [ Time Frame: 3-4 day ]
    Number of embryos day 2/3

  2. Top quality embryos [ Time Frame: 3-4 days ]
    Number of top quality embryos day 2/3. Embryos will be defined as top quality if they will have four cells on Day 2 and/or 7 or 8 cells on Day 3, contain <20% fragmentation, and exhibited no apparent morphological abnormalities.

  3. Pregnancy [ Time Frame: Approximately 2 weeks ]
    Pregnancy is defined as positive βhCG blood test 11-14 days after embryo transfer.

  4. Clinical pregnancy [ Time Frame: Approximately 6 weeks ]
    Clinical pregnancy is defined as gestational sac seen on vaginal ultrasound scan by 6 weeks gestation.

  5. Pregnancy above 8 weeks gestation [ Time Frame: Approximately 8 weeks ]
    Pregnancy above 8 weeks gestation with the appreance of a fetal pulse



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Ages Eligible for Study:   39 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370068


Contacts
Contact: Tal TE Elkan Miller, MD PhD 972546243292 Tal.Miller-Elkan@sheba.health.gov.il
Contact: Jigal JH Haas, MD 972546975372 Jigal.Haas@sheba.health.gov.il

Locations
Israel
IVF Unit, Sheba medical Center Recruiting
Tel HaShomer, Israel
Contact: Tal TE Elkan Miller, MD PHD    972546243292    Tal.Miller-Elkan@sheba.health.gov.il   
Sponsors and Collaborators
Dr. Tal Miller-Elkan
Investigators
Principal Investigator: Tal TE Elkan Miller, MD PhD Sheba Medical Cente

Publications:

Responsible Party: Dr. Tal Miller-Elkan, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03370068     History of Changes
Other Study ID Numbers: SHEBA-17-4531-TEM-CTIL
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Tal Miller-Elkan, Sheba Medical Center:
ICSI
IVF
Infertility
non-male factor
intracytoplasmic sperm injection
In vitro fertilization

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female