ICSI(Ca²⁺)NCT07570342
Comparison of Two Types of Calcium (Ca²⁺) Ionophore Treatments for Oocyte Activation in Cases of Suboptimal Fertilization Potential
A study testing Group 1: Oocyte Activation (OA) CultActive and Group 2: Oocyte Activation (OA) Ionomycin in people with ICSI and Testicular Sperm Extraction in Azoospermic Patients, run by ART Fertility Clinics LLC.
Trial summary
This study aims to investigate the effectiveness and safety of assisted oocyte activation (AOA) using Ca²⁺ ionophores in cases of total fertilization failure (TFF) due to oocyte activation deficiency (OAD). 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
- ICSI, Testicular Sperm Extraction in Azoospermic Patients, Male Infertility
- What is being tested?
- Group 1: Oocyte Activation (OA) CultActive and Group 2: Oocyte Activation (OA) Ionomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
- Patients with a minimum of 3 MII oocytes after denudation.
- Maternal age 18-43 years old.
- PGT-A cycles with only trophectoderm biopsies on day 5/6/7.
- BMI<35.
- Fresh and frozen immotile ejaculated sperm.
Show all 9Show fewer
- Fresh and frozen TESE sperm (motile and immotile).
- Globozoospermia.
- 10. Couples undergoing ICSI due to poor fertilization history (≤30%), or previous fertilization failure.
Who cannot join
- PGT-M/SR cycles.
- Fresh and frozen motile ejaculated / FNA sperm.
- IVF inseminated oocytes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate the effectiveness and safety of assisted oocyte activation (AOA) using Ca²⁺ ionophores in cases of total fertilization failure (TFF) due to oocyte activation deficiency (OAD). The study will be conducted in two phases: Phase I will compare the fertilization rates of oocytes exposed to two types of Ca²⁺ ionophore treatments- Ionomycin solution and commercially available CultActive-against a control group without calcium ionophore treatment. Phase II will assess whether an additional injection of CaCl2, prior to exposure to the chosen ionophore from Phase I, further improves fertilization outcomes. The goal is to identify the optimal AOA protocol for improving fertilization rates and to evaluate the safety and efficacy of this approach in relation to ploidy, with a focus on ensuring normal pre-implantation embryo development.
Read the detailed description
The introduction of ICSI has significantly improved fertilization rates worldwide from 15% to 70-80% between 1996 and 2019. Despite its use, total fertilization failure (TFF) still occurs in 1-5% of cases Oocyte activation deficiency (OAD) is a primary cause of TFF, preventing mature oocytes from undergoing activation and successful fertilization. This deficiency, which can originate from either the sperm or the oocyte, is estimated to contribute directly to 40% of ICSI failures , with potentially higher indirect contributions.
As infertility and ICSI cycles continue to rise, so does the frequency of TFF and OAD. While deficiencies in oocyte-derived factors are more challenging to address and likely involve pathways downstream of sperm-induced activation, the absence of oocyte activation due to deficient sperm-derived signals has been partially overcome through assisted oocyte activation (AOA) approaches. During fertilization, oocyte activation is initiated by sperm-specific phospholipase C zeta (PLCζ), which induces Ca²⁺ oscillations within the oocyte. A disruption in this mechanism is a leading cause of fertilization failure in mammals. Some male etiologies imply deficiencies in sperm PLCζ. In particular, cases of globozoospermia, where sperm lack phospholipase C zeta (PLCζ) and fail to initiate the necessary Ca2+ oscillations for fertilization, have been addressed and proven efficient with AOA. Assisted oocyte activation (AOA) approaches have been proposed as a clinical intervention and have demonstrated some success in compensating for sperm factor deficiencies, by replicating this Ca²⁺ release using mechanical, electrical, or chemical stimulation by Ca²⁺ ionophores. However, concerns regarding its non-physiological nature and incomplete understanding of Ca²⁺ signaling in fertilization limit its widespread implementation.
Ca2+ ionophores are chemical compounds that facilitate the transport of Ca²⁺ ions (Ca²⁺) across biological membranes, bypassing the cells' natural Ca²⁺ signaling mechanisms, therefore they have been applied as AOA biochemical approach. The two most used types of Ca²⁺ Ionophores, are a commercially available Ca2+ Ionophore, A23187 (also known as calcimycin, and is commercially available by Gynemed), a carboxylic antibiotic that binds and freely transports Ca2+ across all biological membranes, and Ionomycin, which is far more specific and potent for Ca²⁺ compared to A23187 and can activate and indirectly stimulate gene expression due to the activation of various Ca²⁺-dependent signaling pathways. Ca2+ signalling is not only essential for nuclear processes such as fertilization mechanisms and cortical granules release, but also for cytoplasmic events such as cytoskeletal rearrangement, mitochondrial function and energy production, and a role in oxidative balance. Although several studies have been published, including a Cochrane review, there have been few randomized controlled trials (RCTs) involving sibling oocytes at the MII stage. Many studies have either included in vitro-matured oocytes or were of retrospective nature, which complicates the interpretation of conclusions regarding the efficacy of the optimal method. Of note, two RCTs using sibling MIIs applied A23187 with no differences in fertilization rates, and only one in Ca²⁺ using Ionomycin which resulted in better fertilization outcomes. Use of CaCl2 in combination to Ca²⁺ ionophore seems to improve outcomes in relation to fertilization without impacting birth characteristics and congenital malformations of the 47 children born. However, safety studies involving preimplantation genetic testing for aneuploidy (PGT-A) on embryos derived from AOA have not been conducted, with only one retrospective report available. Given that for some couples using AOA would mean a last resource to obtain available embryos and for some a significant increase on the availability of embryos, it is crucial to assess both the safety and efficacy by analyzing ploidy and identifying the optimal protocol in this context.
- Being tested
- Group 1: Oocyte Activation (OA) CultActive, Group 2: Oocyte Activation (OA) Ionomycin, Group 3: Control
- Keywords
- ICSI, PGT-A, artificial oocyte activation, AOA, calcium ionophore, ionomycin, TESE, Immotile sperm, Failed fertilization
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Oocyte Activation (OA) CultActiveOther
Oocytes are cultured immediately after injection in a pre-calibrated OA-CultActive dish for 15 min in CO2 incubator, then injected oocytes are rinsed well in culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well.
Group 2: Oocyte Activation (OA) IonomycinOther
Oocytes are placed immediately after injection in a pre-calibrated OA-Ionomycin dish (dish 1) for 7 - 10 min in CO2 incubator, then they are rinsed well and placed in another culture dish (dish 2) for 25 min in CO2 incubator. Then MIIs are exposed again in OA-Ionomycin dish for 10 min, then they are rinsed well and placed into culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well.
Group 3: ControlOther
Oocytes are cultured as per routine practice after injection in culture dish/ Embryoscope slide in routine culture GT-culture medium.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Oocyte Activation (OA) CultActive | Other | Oocytes are cultured immediately after injection in a pre-calibrated OA-CultActive dish for 15 min in CO2 incubator, then injected oocytes are rinsed well in culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. Receives: Other: Group 1: Oocyte Activation (OA) CultActive |
| Group 2: Oocyte Activation (OA) Ionomycin | Other | Oocytes are placed immediately after injection in a pre-calibrated OA-Ionomycin dish (dish 1) for 7 - 10 min in CO2 incubator, then they are rinsed well and placed in another culture dish (dish 2) for 25 min in CO2 incubator. Then MIIs are exposed again in OA-Ionomycin dish for 10 min, then they are rinsed well and placed into culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. Receives: Other: Group 2: Oocyte Activation (OA) Ionomycin |
| Group 3: Control | Other | Oocytes are cultured as per routine practice after injection in culture dish/ Embryoscope slide in routine culture GT-culture medium. Receives: Other: Group 3: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rates and abnormal fertilization.
The primary endpoint is the proportion of metaphase II (MII) oocytes that achieve normal fertilisation (2 pronuclei; 2PN) following insemination or ICSI, compared across study groups. Additionally, the incidence of abnormal fertilisation (e.g., 0PN, 1PN, ≥3PN) will be evaluated. Fertilisation assessment will be performed at the standard time point of 16-20 hours post-insemination/ICSI.
Measured: 16-20 hours post-insemination/ICSI
Oocyte Degeneration Rate
The proportion of metaphase II (MII) oocytes that undergo degeneration following ICSI across the study groups. Degeneration will be assessed at the standard post-ICSI evaluation time point, and expressed as the percentage of injected oocytes exhibiting morphological signs of degeneration.
Measured: 24 hours post-ICSI
Secondary outcomes (3)
Usable Blastocyst Rate
The proportion of normally fertilised oocytes that develop into blastocysts deemed suitable for vitrification or transfer based on established morphological and developmental criteria. The rate will be calculated as the number of usable blastocysts divided by the total number of fertilised oocytes (2PN) within each study group.
Measured: 7 days post fertilization
Blastocyst Quality at Time of Biopsy
Blastocyst quality will be assessed using the modified Gardner blastocyst grading scale, which evaluates blastocyst expansion stage, inner cell mass quality, and trophectoderm quality at the time of biopsy.
The blastocyst expansion stage is scored from 1 to 6, where higher scores indicate a more expanded or hatched blastocyst. The inner cell mass and trophectoderm are graded from A to C, where A indicates the best quality, B indicates intermediate quality, and C indicates the lowest quality. Blastocyst quality scores will be compared across study groups to determine the impact of Ca²⁺ ionophore treatment on blastocyst development.
Measured: 7 days post fertilization
Blastocyst Ploidy on Day 5, 6, or 7
Assessment of chromosomal status of biopsied blastocysts using preimplantation genetic testing (PGT). Ploidy results (euploid, aneuploid, mosaic) will be evaluated and compared across study groups to determine the influence of Ca²⁺ ionophore treatment on chromosomal integrity and embryo competence.
Measured: From enrollment to the end of treatment at 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ICSIStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noreen, ART Fertility Clinics LLC
- Investigators
- BARBARA LAWRENZ, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570342
- Sponsor's protocol ID
- 2503-ABU-008-NH
- Acronym
- (Ca²⁺)
- Status last verified
- Mar 2026
- First submitted
- 30 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Publications
Yeste M, Jones C, Amdani SN, Patel S, Coward K. Oocyte activation deficiency: a role for an oocyte contribution? Hum Reprod Update. 2016 Jan-Feb;22(1):23-47. doi: 10.1093/humupd/dmv040. Epub 2015 Sep 7.
PubMed 26346057Ye Y, Li N, Yan X, Wu R, Zhou W, Cheng L, Li Y. Genetic analysis of embryo in a human case of spontaneous oocyte activation: a case report. Gynecol Endocrinol. 2020 Apr;36(4):294-296. doi: 10.1080/09513590.2019.1687671. Epub 2019 Nov 10.
PubMed 31709844Yang X, Shu L, Cai L, Sun X, Cui Y, Liu J. Homozygous missense mutation Arg207Cys in the WEE2 gene causes female infertility and fertilization failure. J Assist Reprod Genet. 2019 May;36(5):965-971. doi: 10.1007/s10815-019-01418-9. Epub 2019 Mar 2.
PubMed 30826994Tosti E, Menezo Y. Gamete activation: basic knowledge and clinical applications. Hum Reprod Update. 2016 Jun;22(4):420-39. doi: 10.1093/humupd/dmw014. Epub 2016 Jun 8.
PubMed 27278231Tiegs AW, Tao X, Landis J, Zhan Y, Franasiak JM, Seli E, Wells D, Fragouli E, Scott RT Jr. Sperm Mitochondrial DNA Copy Number Is Not a Predictor of Intracytoplasmic Sperm Injection (ICSI) Cycle Outcomes. Reprod Sci. 2020 Jun;27(6):1350-1356. doi: 10.1007/s43032-020-00163-0. Epub 2020 Jan 28.
PubMed 31994001Tesarik J, Rienzi L, Ubaldi F, Mendoza C, Greco E. Use of a modified intracytoplasmic sperm injection technique to overcome sperm-borne and oocyte-borne oocyte activation failures. Fertil Steril. 2002 Sep;78(3):619-24. doi: 10.1016/s0015-0282(02)03291-0.
PubMed 12215343Santella L, Dale B. Assisted yes, but where do we draw the line? Reprod Biomed Online. 2015 Oct;31(4):476-8. doi: 10.1016/j.rbmo.2015.06.013. Epub 2015 Jul 3.
PubMed 26277587Sang Q, Li B, Kuang Y, Wang X, Zhang Z, Chen B, Wu L, Lyu Q, Fu Y, Yan Z, Mao X, Xu Y, Mu J, Li Q, Jin L, He L, Wang L. Homozygous Mutations in WEE2 Cause Fertilization Failure and Female Infertility. Am J Hum Genet. 2018 Apr 5;102(4):649-657. doi: 10.1016/j.ajhg.2018.02.015. Epub 2018 Mar 29.
PubMed 29606300Montag M, Koster M, van der Ven K, Bohlen U, van der Ven H. The benefit of artificial oocyte activation is dependent on the fertilization rate in a previous treatment cycle. Reprod Biomed Online. 2012 May;24(5):521-6. doi: 10.1016/j.rbmo.2012.02.002. Epub 2012 Feb 10.
PubMed 22417664Mateizel I, Verheyen G, Van de Velde H, Tournaye H, Belva F. Obstetric and neonatal outcome following ICSI with assisted oocyte activation by calcium ionophore treatment. J Assist Reprod Genet. 2018 Jun;35(6):1005-1010. doi: 10.1007/s10815-018-1124-6. Epub 2018 Feb 1.
PubMed 29392515Karabulut S, Aksunger O, Ata C, Sagiroglu Y, Keskin I. Artificial oocyte activation with calcium ionophore for frozen sperm cycles. Syst Biol Reprod Med. 2018 Oct;64(5):381-388. doi: 10.1080/19396368.2018.1452311. Epub 2018 Apr 5.
PubMed 29620419Kashir J, Nomikos M, Lai FA. Phospholipase C zeta and calcium oscillations at fertilisation: The evidence, applications, and further questions. Adv Biol Regul. 2018 Jan;67:148-162. doi: 10.1016/j.jbior.2017.10.012. Epub 2017 Oct 27.
PubMed 29108881Kashir J, Mistry BV, BuSaleh L, Abu-Dawas R, Nomikos M, Ajlan A, Abu-Dawud R, AlYacoub N, AlHassan S, Lai FA, Assiri AM, Coskun S. Phospholipase C zeta profiles are indicative of optimal sperm parameters and fertilisation success in patients undergoing fertility treatment. Andrology. 2020 Sep;8(5):1143-1159. doi: 10.1111/andr.12796. Epub 2020 May 20.
PubMed 32298520Kashir J. Increasing associations between defects in phospholipase C zeta and conditions of male infertility: not just ICSI failure? J Assist Reprod Genet. 2020 Jun;37(6):1273-1293. doi: 10.1007/s10815-020-01748-z. Epub 2020 Apr 14.
PubMed 32285298Kamath MS, Vogiatzi P, Sunkara SK, Woodward B. Oocyte activation for women following intracytoplasmic sperm injection (ICSI). Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD014040. doi: 10.1002/14651858.CD014040.pub2.
PubMed 39704318
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Calcium (Ca²⁺) Ionophore Treatments for Oocyte Activation in Cases of Suboptimal Fertilization Potential
- ClinicalTrials.gov ID
- NCT07570342
- Acronym / sponsor ID
- (Ca²⁺) / 2503-ABU-008-NH
- Keywords
- ICSI, PGT-A, artificial oocyte activation, AOA, calcium ionophore, ionomycin, TESE, Immotile sperm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2026 (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.
This study aims to investigate the effectiveness and safety of assisted oocyte activation (AOA) using Ca²⁺ ionophores in cases of total fertilization failure (TFF) due to oocyte activation deficiency (OAD). The study will be conducted in two phases: Phase I will compare the fertilization rates of oocytes exposed to two types of Ca²⁺ ionophore treatments- Ionomycin solution and commercially available CultActive-against a control group without calcium ionophore treatment. Phase II will assess whether an additional injection of CaCl2, prior to exposure to the chosen ionophore from Phase I, further improves fertilization outcomes. The goal is to identify the optimal AOA protocol for improving fertilization rates and to evaluate the safety and efficacy of this approach in relation to ploidy, with a focus on ensuring normal pre-implantation embryo development.
Detailed description
The introduction of ICSI has significantly improved fertilization rates worldwide from 15% to 70-80% between 1996 and 2019. Despite its use, total fertilization failure (TFF) still occurs in 1-5% of cases Oocyte activation deficiency (OAD) is a primary cause of TFF, preventing mature oocytes from undergoing activation and successful fertilization. This deficiency, which can originate from either the sperm or the oocyte, is estimated to contribute directly to 40% of ICSI failures , with potentially higher indirect contributions.
As infertility and ICSI cycles continue to rise, so does the frequency of TFF and OAD. While deficiencies in oocyte-derived factors are more challenging to address and likely involve pathways downstream of sperm-induced activation, the absence of oocyte activation due to deficient sperm-derived signals has been partially overcome through assisted oocyte activation (AOA) approaches. During fertilization, oocyte activation is initiated by sperm-specific phospholipase C zeta (PLCζ), which induces Ca²⁺ oscillations within the oocyte. A disruption in this mechanism is a leading cause of fertilization failure in mammals. Some male etiologies imply deficiencies in sperm PLCζ. In particular, cases of globozoospermia, where sperm lack phospholipase C zeta (PLCζ) and fail to initiate the necessary Ca2+ oscillations for fertilization, have been addressed and proven efficient with AOA. Assisted oocyte activation (AOA) approaches have been proposed as a clinical intervention and have demonstrated some success in compensating for sperm factor deficiencies, by replicating this Ca²⁺ release using mechanical, electrical, or chemical stimulation by Ca²⁺ ionophores. However, concerns regarding its non-physiological nature and incomplete understanding of Ca²⁺ signaling in fertilization limit its widespread implementation.
Ca2+ ionophores are chemical compounds that facilitate the transport of Ca²⁺ ions (Ca²⁺) across biological membranes, bypassing the cells' natural Ca²⁺ signaling mechanisms, therefore they have been applied as AOA biochemical approach. The two most used types of Ca²⁺ Ionophores, are a commercially available Ca2+ Ionophore, A23187 (also known as calcimycin, and is commercially available by Gynemed), a carboxylic antibiotic that binds and freely transports Ca2+ across all biological membranes, and Ionomycin, which is far more specific and potent for Ca²⁺ compared to A23187 and can activate and indirectly stimulate gene expression due to the activation of various Ca²⁺-dependent signaling pathways. Ca2+ signalling is not only essential for nuclear processes such as fertilization mechanisms and cortical granules release, but also for cytoplasmic events such as cytoskeletal rearrangement, mitochondrial function and energy production, and a role in oxidative balance. Although several studies have been published, including a Cochrane review, there have been few randomized controlled trials (RCTs) involving sibling oocytes at the MII stage. Many studies have either included in vitro-matured oocytes or were of retrospective nature, which complicates the interpretation of conclusions regarding the efficacy of the optimal method. Of note, two RCTs using sibling MIIs applied A23187 with no differences in fertilization rates, and only one in Ca²⁺ using Ionomycin which resulted in better fertilization outcomes. Use of CaCl2 in combination to Ca²⁺ ionophore seems to improve outcomes in relation to fertilization without impacting birth characteristics and congenital malformations of the 47 children born. However, safety studies involving preimplantation genetic testing for aneuploidy (PGT-A) on embryos derived from AOA have not been conducted, with only one retrospective report available. Given that for some couples using AOA would mean a last resource to obtain available embryos and for some a significant increase on the availability of embryos, it is crucial to assess both the safety and efficacy by analyzing ploidy and identifying the optimal protocol in this context.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Oocyte Activation (OA) CultActive | Other | Other: Group 1: Oocyte Activation (OA) CultActiveOocytes are cultured immediately after injection in a pre-calibrated OA-CultActive dish for 15 min in CO2 incubator, then injected oocytes are rinsed well in culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. |
| Group 2: Oocyte Activation (OA) Ionomycin | Other | Other: Group 2: Oocyte Activation (OA) IonomycinOocytes are placed immediately after injection in a pre-calibrated OA-Ionomycin dish (dish 1) for 7 - 10 min in CO2 incubator, then they are rinsed well and placed in another culture dish (dish 2) for 25 min in CO2 incubator. Then MIIs are exposed again in OA-Ionomycin dish for 10 min, then they are rinsed well and placed into culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. |
| Group 3: Control | Other | Other: Group 3: ControlOocytes are cultured as per routine practice after injection in culture dish/ Embryoscope slide in routine culture GT-culture medium. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
- Patients with a minimum of 3 MII oocytes after denudation.
- Maternal age 18-43 years old.
- PGT-A cycles with only trophectoderm biopsies on day 5/6/7.
- BMI<35.
Key exclusion criteria (3 listed)
- PGT-M/SR cycles.
- Fresh and frozen motile ejaculated / FNA sperm.
- IVF inseminated oocytes.
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 |
|---|---|---|
| Group 1: Oocyte Activation (OA) CultActiveOocytes are cultured immediately after injection in a pre-calibrated OA-CultActive dish for 15 min in CO2 incubator, then injected oocytes are rinsed well in culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. | Other | Group 1: Oocyte Activation (OA) CultActive |
| Group 2: Oocyte Activation (OA) IonomycinOocytes are placed immediately after injection in a pre-calibrated OA-Ionomycin dish (dish 1) for 7 - 10 min in CO2 incubator, then they are rinsed well and placed in another culture dish (dish 2) for 25 min in CO2 incubator. Then MIIs are exposed again in OA-Ionomycin dish for 10 min, then they are rinsed well and placed into culture dish/ Embryoscope slide in GT-culture medium. Then transferred to the numbered droplet or well. | Other | Group 2: Oocyte Activation (OA) Ionomycin |
| Group 3: ControlOocytes are cultured as per routine practice after injection in culture dish/ Embryoscope slide in routine culture GT-culture medium. | Other | Group 3: Control |
Primary outcome
Fertilization rates and abnormal fertilization.
Time frame: 16-20 hours post-insemination/ICSI
The primary endpoint is the proportion of metaphase II (MII) oocytes that achieve normal fertilisation (2 pronuclei; 2PN) following insemination or ICSI, compared across study groups. Additionally, the incidence of abnormal fertilisation (e.g., 0PN, 1PN, ≥3PN) will be evaluated. Fertilisation assessment will be performed at the standard time point of 16-20 hours post-insemination/ICSI.
Oocyte Degeneration Rate
Time frame: 24 hours post-ICSI
The proportion of metaphase II (MII) oocytes that undergo degeneration following ICSI across the study groups. Degeneration will be assessed at the standard post-ICSI evaluation time point, and expressed as the percentage of injected oocytes exhibiting morphological signs of degeneration.
3 secondary outcomes
Usable Blastocyst Rate
Time frame: 7 days post fertilization
Blastocyst Quality at Time of Biopsy
Time frame: 7 days post fertilization
Blastocyst Ploidy on Day 5, 6, or 7
Time frame: From enrollment to the end of treatment at 4 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Results publication: PubMed 26346057Yeste M, Jones C, Amdani SN, Patel S, Coward K. Oocyte activation deficiency: a role for an oocyte contribution? Hum Reprod Update. 2016 Jan-Feb;22(1):23-47. doi: 10.1093/humupd/dmv040. Epub 2015 Sep 7.
- Results publication: PubMed 31709844Ye Y, Li N, Yan X, Wu R, Zhou W, Cheng L, Li Y. Genetic analysis of embryo in a human case of spontaneous oocyte activation: a case report. Gynecol Endocrinol. 2020 Apr;36(4):294-296. doi: 10.1080/09513590.2019.1687671. Epub 2019 Nov 10.
- Results publication: PubMed 30826994Yang X, Shu L, Cai L, Sun X, Cui Y, Liu J. Homozygous missense mutation Arg207Cys in the WEE2 gene causes female infertility and fertilization failure. J Assist Reprod Genet. 2019 May;36(5):965-971. doi: 10.1007/s10815-019-01418-9. Epub 2019 Mar 2.
- Results publication: PubMed 27278231Tosti E, Menezo Y. Gamete activation: basic knowledge and clinical applications. Hum Reprod Update. 2016 Jun;22(4):420-39. doi: 10.1093/humupd/dmw014. Epub 2016 Jun 8.
- Results publication: PubMed 31994001Tiegs AW, Tao X, Landis J, Zhan Y, Franasiak JM, Seli E, Wells D, Fragouli E, Scott RT Jr. Sperm Mitochondrial DNA Copy Number Is Not a Predictor of Intracytoplasmic Sperm Injection (ICSI) Cycle Outcomes. Reprod Sci. 2020 Jun;27(6):1350-1356. doi: 10.1007/s43032-020-00163-0. Epub 2020 Jan 28.
- Results publication: PubMed 12215343Tesarik J, Rienzi L, Ubaldi F, Mendoza C, Greco E. Use of a modified intracytoplasmic sperm injection technique to overcome sperm-borne and oocyte-borne oocyte activation failures. Fertil Steril. 2002 Sep;78(3):619-24. doi: 10.1016/s0015-0282(02)03291-0.
- Results publication: PubMed 26277587Santella L, Dale B. Assisted yes, but where do we draw the line? Reprod Biomed Online. 2015 Oct;31(4):476-8. doi: 10.1016/j.rbmo.2015.06.013. Epub 2015 Jul 3.
- Results publication: PubMed 29606300Sang Q, Li B, Kuang Y, Wang X, Zhang Z, Chen B, Wu L, Lyu Q, Fu Y, Yan Z, Mao X, Xu Y, Mu J, Li Q, Jin L, He L, Wang L. Homozygous Mutations in WEE2 Cause Fertilization Failure and Female Infertility. Am J Hum Genet. 2018 Apr 5;102(4):649-657. doi: 10.1016/j.ajhg.2018.02.015. Epub 2018 Mar 29.
- Results publication: PubMed 22417664Montag M, Koster M, van der Ven K, Bohlen U, van der Ven H. The benefit of artificial oocyte activation is dependent on the fertilization rate in a previous treatment cycle. Reprod Biomed Online. 2012 May;24(5):521-6. doi: 10.1016/j.rbmo.2012.02.002. Epub 2012 Feb 10.
- Results publication: PubMed 29392515Mateizel I, Verheyen G, Van de Velde H, Tournaye H, Belva F. Obstetric and neonatal outcome following ICSI with assisted oocyte activation by calcium ionophore treatment. J Assist Reprod Genet. 2018 Jun;35(6):1005-1010. doi: 10.1007/s10815-018-1124-6. Epub 2018 Feb 1.
- Results publication: PubMed 29620419Karabulut S, Aksunger O, Ata C, Sagiroglu Y, Keskin I. Artificial oocyte activation with calcium ionophore for frozen sperm cycles. Syst Biol Reprod Med. 2018 Oct;64(5):381-388. doi: 10.1080/19396368.2018.1452311. Epub 2018 Apr 5.
- Results publication: PubMed 29108881Kashir J, Nomikos M, Lai FA. Phospholipase C zeta and calcium oscillations at fertilisation: The evidence, applications, and further questions. Adv Biol Regul. 2018 Jan;67:148-162. doi: 10.1016/j.jbior.2017.10.012. Epub 2017 Oct 27.
- Individual participant dataSharing planned: Undecided. upon request
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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.
BARBARA LAWRENZ study director
ART Fertility Clinics LLC
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Oocyte Activation (OA) CultActive and Group 2: Oocyte Activation (OA) Ionomycin in people with ICSI and Testicular Sperm Extraction in Azoospermic Patients, run by ART Fertility Clinics LLC.
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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JONALYN EDADES, EMBA Healthcare Management (026528000, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rates and abnormal fertilization. (time frame: 16-20 hours post-insemination/ICSI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07570342, which also lists 24 linked publications.
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 11 May 2026.