Using embryo time-lapse morphokinetics to improve IVF birth rates

Do the Morphokinetic Parameters of Early Embryonic Development Have an Interest in the Choice of the Embryo to be Transferred and Improve Birth Rates in Vitro Fertilization

This trial will test whether choosing embryos for transfer using continuous time-lapse monitoring of early development improves birth rates for couples having ICSI for male infertility.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 520 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 2 sites (Caen and 1 other locations)
• Trial ID: NCT03806153 on ClinicalTrials.gov

What this trial studies

Couples undergoing a first or second IVF attempt with ICSI for male infertility will have embryos cultured with time-lapse imaging to record morphokinetic parameters. Embryo selection will incorporate these continuous development timings in addition to standard morphological criteria when deciding which embryo to transfer or freeze. Outcomes will follow transferred embryos through pregnancy to measure birth rates. The intervention is performed at participating university hospital centers in France using fresh ejaculated sperm.

Who should consider this trial

Good fit: Ideal candidates are couples in France where both partners are 18+ (female up to 42, male up to 59), covered by social security, undergoing their first or second IVF attempt with ICSI using fresh ejaculated sperm and with male-factor abnormal semen parameters.

Not a fit: Patients unlikely to benefit include those older than the age limits, couples using donor or frozen sperm, couples beyond a second IVF attempt, or those not treated at the participating centers.

Why it matters

Potential benefit: If successful, this approach could raise the chance of having a baby per IVF cycle by improving single-embryo selection.

How similar studies have performed: Prior studies and meta-analyses show morphokinetic time-lapse can improve embryo selection but evidence for consistent increases in live birth rates is mixed and not definitive.

Eligibility criteria

Inclusion Criteria:

1. For the couple:

   * Couple whose two members are 18 years old and over,
   * Couple whose two members are affiliated to a social security scheme,
   * Couple whose two members read and understood the newsletter and signed the consent form for their participation in this research.
2. For the conditions of realization of the ICSI attempt:

   * Couple supported for a 1st or 2nd attempt at in vitro fertilization with sperm microinjection (ICSI) for male infertility,
   * In vitro fertilization attempt performed with micro-injection of fresh ejaculated spermatozoa.
3. For the man:

   * Couple whose man has an alteration of at least one of the sperm parameters according to the WHO (WHO, 2010) for the number, concentration, vitality, mobility or morphology according to the modified David classification (Auger and Eustache, 2000).

Exclusion Criteria:

1. For the couple:

   * Couple whose wife is under 18 and over 42 and / or the male is under 18 and over 59
   * Couple already included in the protocol "EMCIMO" for a previous attempt,
   * Couple of which one or both members is deprived by an administrative or judicial decision or subject to a legal measure of protection of the majors (safeguard of justice or tutelage or curatorship),
   * Couple where one or both members do not speak or understand French.
2. For the conditions of realization of the ICSI attempt:

   \- In vitro fertilization attempt with the micro-injection of testicular spermatozoa, epididymal, previously frozen or resulting from a retrograde ejaculation.
3. For the man:

   * Severe oligozoospermia (\<100,000 spermatozoa / ejaculate).

Where this trial is running

Caen and 1 other locations

• Chu Caen — Caen, France (Recruiting)
• Chu Rouen — Rouen, France (Recruiting)

Conditions Reproductive Disorder