Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
- Conditions
- Infertility
- Interventions
- Other: overnight exposure to sperm for IVFOther: 2h exposure to sperm for IVF
- Registration Number
- NCT04627545
- Lead Sponsor
- ART Fertility Clinics LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 55
-
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)
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≥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
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Couples requesting Preimplantation Genetic Testing for Aneuploidies
-
Arab population
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVF: overnight exposure overnight exposure to sperm for IVF Half of a patients' oocytes will be subjected to overnight incubation with sperm (=usual practice). IVF: 2h exposure 2h exposure to sperm for IVF Half of a patients' oocytes will be subjected to 2h exposure to sperm
- Primary Outcome Measures
Name Time Method Normal fertilization rate 2 days presence of two pronuclei per inseminated oocyte
- Secondary Outcome Measures
Name Time Method Day of trophectoderm biopsy 8 days Day at which the blastocyst reaches sufficient expansion to perform biopsy of trophectoderm cells
Maturation rate 2 days number of mature oocytes obtained in each arm
Total fertilization failure 3 days Number of cycles with complete fertilization failure (in one arm or in both arms)
blastulation rate I 8 days number of embryos reaching at least the BL1 stage/ number of oocytes assigned to that group: defined by a 1 (yes, the embryo is blastulating) or 0 (no, the embryo is not blastulating)
Number of COCs assigned to each group 2 days number of oocytes, per patient, assigned to each exposure group
blastulation rate II 8 days number of embryos reaching at least the BL1 stage/ number of mature oocytes in that group: defined by a 1 (yes, the embryo is blastulating) or 0 (no, the embryo is not blastulating)
Euploid rate 8 days Number of genetically normal embryos per total number of blastocysts biopsied, stratified per day of biopsy
Clinical pregnancy Fetal Heart beat positive 80 days dichotomous variable defined by the ultrasonographic visualization of one or more gestational sacs, with fetal heart beat at 7 weeks.
Fertilization 3 days Number of abnormally fertilized oocytes and failed fertilization
Embryo quality on day 3 5 days defined by the Istanbul consensus (Alpha Scientists, 2011) The number of blastomeres and their division pattern, fragmentation, presence of compaction, vacuoles, granulation and nuclei will divide the embryos into 3 categories: good, fair or poor
Utilization rate 8 days number of embryos that can be used for the patient (=number of embryos that can be biopsied)/number of oocytes assigned to the group
Morphokinetic parameters 10 days As embryos will be monitored in a time lapse imaging system, morphokinetic parameters will be compared between both exposure arms: o t2: the timing to two cells
* t3: the timing to three cells
* t4: the timing to four cells
* t5: the timing to five cells
* t8: the timing to eight cells
* SC: starting to compact
* M: the timing to morula
* SB: starting to blastulate
* B: reaching a BL3 according to Gardner and Schoolcraft, 1999
* F: reaching a BL4 according to Gardner and Schoolcraft, 1999
* cc2: t3-t2
* s2: t4-t3Embryo quality on day 5 8 days defined by a modified model of Gardner and Schoolcraft,1999
Pregnancy outcome 60 days dichotomous variable defined by the presence of βhCG test of \> 15IU 12-15 days after embryo transfer
Biochemical pregnancy 70 days dichotomous variable defined as a pregnancy in which the hCG levels start do decrease after 1 week
Implantation rate 80 days defined by the number of gestational sacs/number of embryos transferred
• Clinical pregnancy (yes or no) defined by the ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancies
Trial Locations
- Locations (1)
ART Fertility Clinics
🇦🇪Abu Dhabi, United Arab Emirates