InfertilityNCT04627545
Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
A study testing 2h exposure to sperm for IVF and overnight exposure to sperm for IVF in people with Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- 2h exposure to sperm for IVF and overnight exposure to sperm for IVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 3 Nov 2020to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- 2h exposure to sperm for IVF, overnight exposure to sperm for IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2h exposure to sperm for IVFOther
Also called short exposure
Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination
overnight exposure to sperm for IVFOther
Also called long exposure
Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination
| Study group | Role | What they receive |
|---|---|---|
| IVF: 2h exposure | Experimental | Half of a patients' oocytes will be subjected to 2h exposure to sperm Receives: Other: 2h exposure to sperm for IVF |
| IVF: overnight exposure | Active comparator | Half of a patients' oocytes will be subjected to overnight incubation with sperm (=usual practice). Receives: Other: overnight exposure to sperm for IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal fertilization rate
presence of two pronuclei per inseminated oocyte
Measured: 2 days
Secondary outcomes (16)
Number of COCs assigned to each group
number of oocytes, per patient, assigned to each exposure group
Measured: 2 days
Maturation rate
number of mature oocytes obtained in each arm
Measured: 2 days
Fertilization
Number of abnormally fertilized oocytes and failed fertilization
Measured: 3 days
Total fertilization failure
Number of cycles with complete fertilization failure (in one arm or in both arms)
Measured: 3 days
Embryo quality on day 3
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
Measured: 5 days
Embryo quality on day 5
defined by a modified model of Gardner and Schoolcraft,1999
Measured: 8 days
blastulation rate I
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)
Measured: 8 days
blastulation rate II
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)
Measured: 8 days
Utilization rate
number of embryos that can be used for the patient (=number of embryos that can be biopsied)/number of oocytes assigned to the group
Measured: 8 days
Day of trophectoderm biopsy
Day at which the blastocyst reaches sufficient expansion to perform biopsy of trophectoderm cells
Measured: 8 days
Euploid rate
Number of genetically normal embryos per total number of blastocysts biopsied, stratified per day of biopsy
Measured: 8 days
Morphokinetic parameters
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
Measured: 10 days
Pregnancy outcome
dichotomous variable defined by the presence of βhCG test of > 15IU 12-15 days after embryo transfer
Measured: 60 days
Biochemical pregnancy
dichotomous variable defined as a pregnancy in which the hCG levels start do decrease after 1 week
Measured: 70 days
Implantation rate
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
Measured: 80 days
Clinical pregnancy Fetal Heart beat positive
dichotomous variable defined by the ultrasonographic visualization of one or more gestational sacs, with fetal heart beat at 7 weeks.
Measured: 80 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start3 Nov 2020
- Primary completion1 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neelke De Munck, PhD, Principal investigator, ART Fertility Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627545
- Sponsor's protocol ID
- 2010-ABU-010-ND
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2020
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The principal investigator will gather all data for the study and prepare the database for the statistician, who will be blinded for patient information.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time
- ClinicalTrials.gov ID
- NCT04627545
- Acronym / sponsor ID
- 2010-ABU-010-ND
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| IVF: 2h exposure | Experimental | Other: 2h exposure to sperm for IVFHalf of a patients' oocytes will be subjected to 2h exposure to sperm |
| IVF: overnight exposure | Active comparator | Other: overnight exposure to sperm for IVFHalf of a patients' oocytes will be subjected to overnight incubation with sperm (=usual practice). |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Sperm parameters
- ≥6 COCs assigned to IVF
- BMI ≤35 kg/m2
- Female age 18 to ≤ 43 years
- All ovarian stimulation protocols
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2h exposure to sperm for IVFAlso: short exposureOocytes will only be briefly (2h) exposed to progressive motile sperm for insemination | Other | IVF: 2h exposure |
| overnight exposure to sperm for IVFAlso: long exposureOocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination | Other | IVF: overnight exposure |
Primary outcome
Normal fertilization rate
Time frame: 2 days
presence of two pronuclei per inseminated oocyte
16 secondary outcomes
Number of COCs assigned to each group
Time frame: 2 days
Maturation rate
Time frame: 2 days
Fertilization
Time frame: 3 days
Total fertilization failure
Time frame: 3 days
Embryo quality on day 3
Time frame: 5 days
Embryo quality on day 5
Time frame: 8 days
blastulation rate I
Time frame: 8 days
blastulation rate II
Time frame: 8 days
Utilization rate
Time frame: 8 days
Day of trophectoderm biopsy
Time frame: 8 days
Euploid rate
Time frame: 8 days
Morphokinetic parameters
Time frame: 10 days
Pregnancy outcome
Time frame: 60 days
Biochemical pregnancy
Time frame: 70 days
Implantation rate
Time frame: 80 days
Clinical pregnancy Fetal Heart beat positive
Time frame: 80 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No. The principal investigator will gather all data for the study and prepare the database for the statistician, who will be blinded for patient information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neelke De Munck, PhD principal investigator
ART Fertility Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2h exposure to sperm for IVF and overnight exposure to sperm for IVF in people with Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal fertilization rate (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.