Clinical trial NCT04627545: Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
Official title: Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Oocytes of one patient will be evenly and randomly distributed between two timings of exposure to sperm: 2h exposure versus overnight exposure (16-20h)
Primary purpose: TREATMENT

Brief summary: The current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). As secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.

Detailed description: All patients for whom at least 6 cumulus oocytes complexes (COCs) are assigned to IVF, with normal sperm parameters, are eligible for the study. An electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. In case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. In this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Sperm parameters

  * Sperm concentration before capacitation: \>15 million per ml (WHO) Total motility (PR+NP %): \>40 (WHO) Progressive motility (PR %):\>32 (WHO)
  * Sperm concentration after capacitation: \>0.6 million per ml (not WHO defined) Progressive motility (PR %):\>65 (WHO)
* ≥6 COCs assigned to IVF
* BMI ≤35 kg/m2
* Female age 18 to ≤ 43 years
* All ovarian stimulation protocols
* Fresh ejaculates
* Abstinence duration 2-5 days
* Presence or absence of sperm morphology data: as we do not have a diagnostic sperm analysis for all patients, the presence or absence of \>4% normal morphology (WHO) will not be taken into account, even with known low (\<4%) normal morphology
* Couples requesting Preimplantation Genetic Testing for Aneuploidies
* Arab population

Exclusion Criteria:

* If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
* Presence of \>1 million per ml round cells in the ejaculate
* If a couple's previous cycle was included in the study
* Previous history of fertilization failure or \<50% fertilisation
* Globozoospermia
* PCO according to the Rotterdam criteria
* Progesterone \>1.5 ng/ml on the day of trigger

Primary outcomes:
measure: Normal fertilization rate
timeFrame: 2 days
Secondary outcomes:
measure: Number of COCs assigned to each group
timeFrame: 2 days
measure: Maturation rate
timeFrame: 2 days
measure: Fertilization
timeFrame: 3 days
measure: Total fertilization failure
timeFrame: 3 days
measure: Embryo quality on day 3
timeFrame: 5 days
measure: Embryo quality on day 5
timeFrame: 8 days
measure: blastulation rate I
timeFrame: 8 days
measure: blastulation rate II
timeFrame: 8 days
measure: Utilization rate
timeFrame: 8 days
measure: Day of trophectoderm biopsy
timeFrame: 8 days
measure: Euploid rate
timeFrame: 8 days
measure: Morphokinetic parameters
timeFrame: 10 days
measure: Pregnancy outcome
timeFrame: 60 days
measure: Biochemical pregnancy
timeFrame: 70 days
measure: Implantation rate
timeFrame: 80 days
measure: Clinical pregnancy Fetal Heart beat positive
timeFrame: 80 days
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics
Study officials:
affiliation: ART Fertility Clinics
name: Neelke De Munck, PhD
role: PRINCIPAL_INVESTIGATOR
References: