Will intracytoplasmic morphologically selected sperm injection replace intracytoplasmic sperm injection in cases of severe oligo-astheno-teratozoospermia ? A prospective study comparing pregnancy outcome

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000668505
• Date of registration: 26/06/2015
• Prospective Registration: No
• Primary sponsor: alexandria university, faculty of medicne
• Public title: Will intracytoplasmic morphologically selected sperm injection replace intracytoplasmic sperm injection in cases of severe oligo-astheno-teratozoospermia ? A prospective study comparing pregnancy outcome
• Scientific title: Is intracytoplasmic morphologically selected sperm injection (IMSI) more effective than intracytoplasmic sperm injection (ISCI) in cases of severe oligo-astheno-teratozoospermia? A prospective study regarding pregnancy outcome
• Date of first enrolment: 01/10/2012
• Target sample size: 1729
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000668505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;

Countries of recruitment

Egypt

Contacts

• Name: A/Prof yasser orief

• Name: A/Prof yasser orief

Key inclusion & exclusion criteria

Inclusion criteria: very poor semen quality characterized by severe oligo-astheno-teratozoospermia (sperm concentration less than 5 million per ml, less than 50% motile sperms according to WHO criteria and less than 14% morphologically normal spermatozoa according to the Strict Kruger Criteria), a normal karyotype in both partners
.

Exclusion criteria: Uterine defects, hydrosalpinx, endometriosis, polycystic ovaries, evidence of low ovarian response in previous treatment cycles (less than four oocytes retrieved), infections, endocrinal problems, coagulation defects or thrombophilia and autoimmune defects (including antiphospholipid antibodies) were all excluded.

Age minimum: 25 Years
Age maximum: 45 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

male factor infertility and IMSI;
male factor infertility and IMSI

Reproductive Health and Childbirth - Fertility including in vitro fertilisation

Intervention(s)

All the cases with severe oligoathenospermia (OAT) from 2012 to 2013 were counseled about the efficacy of the intracystoplasmic morphologicaly selected sperm injection (IMSI ) technique and its possible role for increasing the pregnancy rate, those accepted and consented on the new technique were enrolled in the study for IMSI group. For IMSI, spermatozoa were selected at 6600× magnification using an inverted microscope equipped with Nomarski (differential interference contrast) optics.
it may be administered on multiple occasions within a given time period.
IMSI is an advanced and sophisticated method of ICSI, where prior to sperm injection, the morphology of the sperm is evaluated under high magnification. In addition, the IMSI procedure involves a few minor modifications in sperm preparation which are not carried out during the conventional ICSI procedure, such as the use of MSOME criteria, the requirement for a glass-bottomed dish for selection, prolonged sperm manipulation following separation from the seminal fluid, and sperm storage prior to microinjection.

The maximal number of times that this procedure may be undertaken in each couple is 3 times, and the overall duration of the intervention period is once every 2 months.

Primary Outcome(s)

The primary outcome measure is the pregnancy rate which is diagnosed by positive serum beta-hCG assay (> 50 IU/L) 14 days after embryo transfer (ET) . Moreover, clinical pregnancy is confirmed by observing the number of the gestational sacs and fetal cardiac pulsations 2 weeks after positive beta -hCG test by trans-vaginal ultrasonography (TVS).
[one year]

Secondary Outcome(s)

embryo grade by microscopy[5days]

Fertilization rate[One month]

Secondary ID(s)

nil

Source(s) of Monetary Support

yasser orief