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Completed

NCT Number: NCT04627545

Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ART Fertility Clinics

Abu Dhabi, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2h exposure to sperm for IVF

Other

Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination

Other names: short exposure

overnight exposure to sperm for IVF

Other

Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination

Other names: long exposure

Primary outcomes

  1. Normal fertilization rate

    Time frame: 2 days

    presence of two pronuclei per inseminated oocyte

Secondary outcomes

  1. Number of COCs assigned to each group

    Time frame: 2 days

    number of oocytes, per patient, assigned to each exposure group

  2. Maturation rate

    Time frame: 2 days

    number of mature oocytes obtained in each arm

  3. Fertilization

    Time frame: 3 days

    Number of abnormally fertilized oocytes and failed fertilization

  4. Total fertilization failure

    Time frame: 3 days

    Number of cycles with complete fertilization failure (in one arm or in both arms)

  5. Embryo quality on day 3

    Time frame: 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

  6. Embryo quality on day 5

    Time frame: 8 days

    defined by a modified model of Gardner and Schoolcraft,1999

  7. blastulation rate I

    Time frame: 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)

  8. blastulation rate II

    Time frame: 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)

  9. Utilization rate

    Time frame: 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

  10. Day of trophectoderm biopsy

    Time frame: 8 days

    Day at which the blastocyst reaches sufficient expansion to perform biopsy of trophectoderm cells

  11. Euploid rate

    Time frame: 8 days

    Number of genetically normal embryos per total number of blastocysts biopsied, stratified per day of biopsy

  12. Morphokinetic parameters

    Time frame: 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-t3

  13. Pregnancy outcome

    Time frame: 60 days

    dichotomous variable defined by the presence of βhCG test of > 15IU 12-15 days after embryo transfer

  14. Biochemical pregnancy

    Time frame: 70 days

    dichotomous variable defined as a pregnancy in which the hCG levels start do decrease after 1 week

  15. Implantation rate

    Time frame: 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

  16. Clinical pregnancy Fetal Heart beat positive

    Time frame: 80 days

    dichotomous variable defined by the ultrasonographic visualization of one or more gestational sacs, with fetal heart beat at 7 weeks.

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2020
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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