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
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female||Other: ICSI Other: Conventional IVF||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
All the oocytes in this group (from one ovary) will undergo insemination by 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
- Fertilization [ Time Frame: 1 day ]The number of fertilized oocytes
- Embryos [ Time Frame: 3-4 day ]Number of embryos day 2/3
- 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.
- Pregnancy [ Time Frame: Approximately 2 weeks ]Pregnancy is defined as positive βhCG blood test 11-14 days after embryo transfer.
- Clinical pregnancy [ Time Frame: Approximately 6 weeks ]Clinical pregnancy is defined as gestational sac seen on vaginal ultrasound scan by 6 weeks gestation.
- Pregnancy above 8 weeks gestation [ Time Frame: Approximately 8 weeks ]Pregnancy above 8 weeks gestation with the appreance of a fetal pulse
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370068
|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|
|IVF Unit, Sheba medical Center||Recruiting|
|Tel HaShomer, Israel|
|Contact: Tal TE Elkan Miller, MD PHD 972546243292 Tal.Miller-Elkan@sheba.health.gov.il|
|Principal Investigator:||Tal TE Elkan Miller, MD PhD||Sheba Medical Cente|