Diminished Ovarian ReserveExosom2025-1NCT07249411
In Vitro Oocyte Maturation With Autologous Exosomes in Women
A study testing MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system in people with Diminished Ovarian Reserve, run by Biotech Fertility C.A. at 1 site in Venezuela.
Trial summary
This study is a preliminary, prospective, randomized, controlled clinical trial designed to evaluate the safety and feasibility of supplementing in vitro maturation (IVM) media with autologous exosomes in women with diminished ovarian reserve undergoing assisted reproductive technology. Read more about this study
- Who is it for?
- Ages 38 to 48 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteVenezuela
- Study dates
- 2 Jan 2023to 31 Jan 2025
- 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 38 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with primary or secondary infertility associated with diminished ovarian reserve, defined by ultrasound findings and laboratory parameters (FSH > 10 mIU/mL and estradiol < 60 pg/mL).
- Serum anti-Müllerian hormone (AMH) concentration < 1 ng/mL.
- Antral follicle count < 3-6 follicles per ovary.
- Anatomical preservation of both ovaries.
- Body mass index (BMI) between 24.5 and 30 kg/m².
- Absence of active oncological pathologies or connective tissue diseases (collagenopathies).
Show all 13Show fewer
- No history of clinically relevant hematological disorders.
- Adequate serum levels of vitamins essential for reproductive function, including vitamin D, B-complex, and vitamin C.
- Last live birth within ≤ 10 years prior to study initiation.
- Normal thyroid function (TSH and free thyroid hormones within range).
- Absence of antiphospholipid antibody syndrome.
- Male partner with semen parameters within normal limits, according to the World Health Organization (WHO) criteria, 2010 (5th edition) and 2021 (6th edition).
- Signed informed consent for participation in the study.
Who cannot join
- • Patients without a diagnosis of infertility.
- Women without documented diminished ovarian reserve.
- Serum anti-Müllerian hormone (AMH) concentration > 1 ng/mL.
- Antral follicle count > 3-6 follicles per ovary.
- Absence of one or both ovaries.
- Body mass index (BMI) > 30 kg/m².
Show all 14Show fewer
- Presence of active oncological pathologies or connective tissue diseases (collagenopathies).
- History of clinically relevant hematological disorders.
- Deficient or altered serum levels of vitamins essential for reproductive function (vitamin D, B-complex, and vitamin C).
- Last live birth > 10 years prior to study initiation.
- Altered thyroid function (TSH or free thyroid hormones out of range).
- History of antiphospholipid antibody syndrome.
- Male partner with abnormal semen parameters according to the World Health Organization (WHO) criteria, 2010 (5th edition) and 2021 (6th edition).
- Refusal to sign informed consent for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Oocyte Maturation With Autologous Exosomes in Women With Low Ovarian Reserve: Preliminary Phase of a Prospective Randomized Clinical Study
This study is a preliminary, prospective, randomized, controlled clinical trial designed to evaluate the safety and feasibility of supplementing in vitro maturation (IVM) media with autologous exosomes in women with diminished ovarian reserve undergoing assisted reproductive technology. The purpose of the study is to determine whether autologous exosomes can support the meiotic progression of immature metaphase I oocytes during a 24-36 hour culture period and to establish whether the intervention is safe, biologically feasible, and suitable for further clinical evaluation. Mature oocytes obtained after culture are fertilized using intracytoplasmic sperm injection, and resulting embryos are cryopreserved for future transfer in a subsequent phase of the research. No embryo transfer is performed during this preliminary phase.
Read the detailed description
Women with diminished ovarian reserve frequently present a high proportion of immature oocytes after controlled ovarian stimulation. These immature oocytes cannot be fertilized and limit the number of mature oocytes available for assisted reproductive procedures. Oocyte maturation is regulated by a coordinated set of intracellular signaling pathways, intercellular communication with granulosa cells, and molecular mechanisms that maintain meiotic arrest and trigger meiotic resumption. Emerging scientific evidence indicates that extracellular vesicles, including autologous exosomes, may play a role in supporting oocyte maturation through the transfer of bioactive molecules.
This preliminary clinical study was designed to evaluate the safety and feasibility of using autologous exosomes as a supplement to conventional in vitro maturation (IVM) media. The study population includes women aged 38-46 years with documented diminished ovarian reserve who declined oocyte donation and who met predefined clinical, endocrine, and reproductive criteria. All participants provided written informed consent. The study was conducted in accordance with national regulations and international ethical principles for research involving human subjects.
Eligible participants undergo controlled ovarian stimulation using recombinant follicle-stimulating hormone, human menopausal gonadotropin, and an antagonist protocol, followed by human chorionic gonadotropin triggering and oocyte retrieval. Only metaphase I oocytes are included in the intervention portion of the study. After identification, metaphase I oocytes are randomly assigned to one of two groups using a simple computer-generated randomization method.
In the control group, oocytes are cultured in conventional in vitro maturation medium. In the experimental group, oocytes are cultured in the same medium supplemented with a standardized quantity of autologous exosomes isolated from each participant according to the study protocol. Culture duration ranges from 24 to 36 hours. After the culture period, oocytes reaching metaphase II are fertilized via intracytoplasmic sperm injection to standardize the fertilization procedure. Embryos developing after fertilization are cultured under standardized laboratory conditions, evaluated according to established morphological criteria, and cryopreserved for use in a future phase of the research. Embryo transfer is not performed during this preliminary phase.
The primary objective of the study is to assess whether autologous exosome supplementation is feasible and safe for use in IVM culture systems. Secondary objectives include documenting the procedures involved in oocyte handling, fertilization, and embryo cryopreservation to support future phases of the study. The study does not include analysis of results or clinical outcomes, as no outcomes are permitted to be reported in the Protocol Section of the ClinicalTrials.gov record. A subsequent phase of the research will evaluate implantation, clinical pregnancy, and live birth after transfer of cryopreserved embryos generated in this protocol.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system
- Keywords
- Oocyte maturation, Meiotic arrest, In vitro maturation, Autologous exosomes, Diminished ovarian reserve, Assisted reproductive technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration systemOther
MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system
| Study group | Role | What they receive |
|---|---|---|
| MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes o | Active comparator | * Group I (Control): MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®).
* Group II (Experimental): MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system Receives: Other: MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system |
| MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). | Active comparator | MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). Receives: Other: MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Metaphase I Oocytes Reaching Metaphase II After In Vitro Cultureautologous exosomes obtained using the ExoSMarT® exosome filtration system
This measure evaluates the number and proportion of metaphase I oocytes that progress to the metaphase II stage after 24-36 hours of in vitro culture in either conventional IVM medium or IVM medium supplemented with autologous exosomes. Maturation will be identified by the presence of the first polar body. Data will be summarized as a proportion of total metaphase I oocytes cultured.
Measured: 24-36 hours
Number of Mature Oocytes Fertilized After Intracytoplasmic Sperm Injection (ICSI)
This measure records the number and proportion of in vitro-matured metaphase II oocytes that demonstrate normal fertilization after ICSI, defined by the presence of two pronuclei under standard embryology laboratory criteria.
Measured: Approximately 18 hours after ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 Jan 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diminished Ovarian ReserveStudies 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
- prospective, randomized, controlled clinical trial designed to evaluate the safety and efficacy of the intervention in women diagnosed with infertility.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Fertility C.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Navarro, Biotech Fertility C.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249411
- Sponsor's protocol ID
- Exosom2025-1
- Acronym
- Exosom2025-1
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not but the individual participant data (IPD) from this study will be available to other qualified researchers upon reasonable request. Data sharing will be granted after a formal email request specifying the investigator's identity, institutional affiliation, and research objective. Access will be provided only for scientifically justified purposes, in compliance with confidentiality agreements and ethical standards protecting participant privacy.
Publications
Mehlmann LM. Stops and starts in mammalian oocytes: recent advances in understanding the regulation of meiotic arrest and oocyte maturation. Reproduction. 2005 Dec;130(6):791-9. doi: 10.1530/rep.1.00793.
PubMed 16322539Chand AL, Legge M. Amino acid transport system L activity in developing mouse ovarian follicles. Hum Reprod. 2011 Nov;26(11):3102-8. doi: 10.1093/humrep/der298. Epub 2011 Sep 13.
PubMed 21914669Dupont S, Krust A, Gansmuller A, Dierich A, Chambon P, Mark M. Effect of single and compound knockouts of estrogen receptors alpha (ERalpha) and beta (ERbeta) on mouse reproductive phenotypes. Development. 2000 Oct;127(19):4277-91. doi: 10.1242/dev.127.19.4277.
PubMed 10976058Kiyama R, Wada-Kiyama Y. Estrogenic endocrine disruptors: Molecular mechanisms of action. Environ Int. 2015 Oct;83:11-40. doi: 10.1016/j.envint.2015.05.012. Epub 2015 Jun 11.
PubMed 26073844Coticchio G, Dal Canto M, Mignini Renzini M, Guglielmo MC, Brambillasca F, Turchi D, Novara PV, Fadini R. Oocyte maturation: gamete-somatic cells interactions, meiotic resumption, cytoskeletal dynamics and cytoplasmic reorganization. Hum Reprod Update. 2015 Jul-Aug;21(4):427-54. doi: 10.1093/humupd/dmv011. Epub 2015 Mar 4.
PubMed 25744083Esbert M, Reig A, Ballestros A, Seli E. Oocyte maturation defect in women undergoing IVF: contributing factors and effects on mature sibling oocyte outcomes. J Assist Reprod Genet. 2025 Mar;42(3):773-780. doi: 10.1007/s10815-024-03353-w. Epub 2025 Jan 9.
PubMed 39786528Coticchio G, Cimadomo D, Rienzi L. The daunting goal to rescue oocytes collected immature in conventional ovarian stimulation cycles. Fertil Steril. 2025 May;123(5):747-748. doi: 10.1016/j.fertnstert.2025.02.026. Epub 2025 Feb 22.
PubMed 39993495Navarro C, Torrecillas Cabrera P, Teppa Garran A. Comparative analysis of the use of autologous exosomes and platelet-derived growth factors in women with premature ovarian insufficiency and infertility: A prospective, randomized, observational, analytical study. Regen Ther. 2025 Jun 30;30:309-320. doi: 10.1016/j.reth.2025.06.007. eCollection 2025 Dec.
PubMed 40678344Tornell J, Billig H, Hillensjo T. Resumption of rat oocyte meiosis is paralleled by a decrease in guanosine 3',5'-cyclic monophosphate (cGMP) and is inhibited by microinjection of cGMP. Acta Physiol Scand. 1990 Jul;139(3):511-7. doi: 10.1111/j.1748-1716.1990.tb08953.x.
PubMed 2173353Cho WK, Stern S, Biggers JD. Inhibitory effect of dibutyryl cAMP on mouse oocyte maturation in vitro. J Exp Zool. 1974 Mar;187(3):383-6. doi: 10.1002/jez.1401870307. No abstract available.
PubMed 4362350Dekel N, Beers WH. Development of the rat oocyte in vitro: inhibition and induction of maturation in the presence or absence of the cumulus oophorus. Dev Biol. 1980 Mar 15;75(2):247-54. doi: 10.1016/0012-1606(80)90160-8. No abstract available.
PubMed 6154623Schultz RM, Montgomery RR, Belanoff JR. Regulation of mouse oocyte meiotic maturation: implication of a decrease in oocyte cAMP and protein dephosphorylation in commitment to resume meiosis. Dev Biol. 1983 Jun;97(2):264-73. doi: 10.1016/0012-1606(83)90085-4.
PubMed 6189752Horner K, Livera G, Hinckley M, Trinh K, Storm D, Conti M. Rodent oocytes express an active adenylyl cyclase required for meiotic arrest. Dev Biol. 2003 Jun 15;258(2):385-96. doi: 10.1016/s0012-1606(03)00134-9.
PubMed 12798295Hinckley M, Vaccari S, Horner K, Chen R, Conti M. The G-protein-coupled receptors GPR3 and GPR12 are involved in cAMP signaling and maintenance of meiotic arrest in rodent oocytes. Dev Biol. 2005 Nov 15;287(2):249-61. doi: 10.1016/j.ydbio.2005.08.019. Epub 2005 Oct 17.
PubMed 16229830Kovanci E, Rohozinski J, Simpson JL, Heard MJ, Bishop CE, Carson SA. Growth differentiating factor-9 mutations may be associated with premature ovarian failure. Fertil Steril. 2007 Jan;87(1):143-6. doi: 10.1016/j.fertnstert.2006.05.079. Epub 2006 Dec 6.
PubMed 17156781
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Oocyte Maturation With Autologous Exosomes in Women With Low Ovarian Reserve: Preliminary Phase of a Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07249411
- Acronym / sponsor ID
- Exosom2025-1 / Exosom2025-1
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Oocyte maturation, Meiotic arrest, In vitro maturation, Autologous exosomes, Diminished ovarian reserve, Assisted reproductive technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biotech Fertility C.A.University, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 25 Nov 2025 (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 is a preliminary, prospective, randomized, controlled clinical trial designed to evaluate the safety and feasibility of supplementing in vitro maturation (IVM) media with autologous exosomes in women with diminished ovarian reserve undergoing assisted reproductive technology. The purpose of the study is to determine whether autologous exosomes can support the meiotic progression of immature metaphase I oocytes during a 24-36 hour culture period and to establish whether the intervention is safe, biologically feasible, and suitable for further clinical evaluation. Mature oocytes obtained after culture are fertilized using intracytoplasmic sperm injection, and resulting embryos are cryopreserved for future transfer in a subsequent phase of the research. No embryo transfer is performed during this preliminary phase.
Detailed description
Women with diminished ovarian reserve frequently present a high proportion of immature oocytes after controlled ovarian stimulation. These immature oocytes cannot be fertilized and limit the number of mature oocytes available for assisted reproductive procedures. Oocyte maturation is regulated by a coordinated set of intracellular signaling pathways, intercellular communication with granulosa cells, and molecular mechanisms that maintain meiotic arrest and trigger meiotic resumption. Emerging scientific evidence indicates that extracellular vesicles, including autologous exosomes, may play a role in supporting oocyte maturation through the transfer of bioactive molecules.
This preliminary clinical study was designed to evaluate the safety and feasibility of using autologous exosomes as a supplement to conventional in vitro maturation (IVM) media. The study population includes women aged 38-46 years with documented diminished ovarian reserve who declined oocyte donation and who met predefined clinical, endocrine, and reproductive criteria. All participants provided written informed consent. The study was conducted in accordance with national regulations and international ethical principles for research involving human subjects.
Eligible participants undergo controlled ovarian stimulation using recombinant follicle-stimulating hormone, human menopausal gonadotropin, and an antagonist protocol, followed by human chorionic gonadotropin triggering and oocyte retrieval. Only metaphase I oocytes are included in the intervention portion of the study. After identification, metaphase I oocytes are randomly assigned to one of two groups using a simple computer-generated randomization method.
In the control group, oocytes are cultured in conventional in vitro maturation medium. In the experimental group, oocytes are cultured in the same medium supplemented with a standardized quantity of autologous exosomes isolated from each participant according to the study protocol. Culture duration ranges from 24 to 36 hours. After the culture period, oocytes reaching metaphase II are fertilized via intracytoplasmic sperm injection to standardize the fertilization procedure. Embryos developing after fertilization are cultured under standardized laboratory conditions, evaluated according to established morphological criteria, and cryopreserved for use in a future phase of the research. Embryo transfer is not performed during this preliminary phase.
The primary objective of the study is to assess whether autologous exosome supplementation is feasible and safe for use in IVM culture systems. Secondary objectives include documenting the procedures involved in oocyte handling, fertilization, and embryo cryopreservation to support future phases of the study. The study does not include analysis of results or clinical outcomes, as no outcomes are permitted to be reported in the Protocol Section of the ClinicalTrials.gov record. A subsequent phase of the research will evaluate implantation, clinical pregnancy, and live birth after transfer of cryopreserved embryos generated in this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled clinical trial designed to evaluate the safety and efficacy of the intervention in women diagnosed with infertility.
| Arm | Type | Receives |
|---|---|---|
| MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes o | Active comparator | Other: MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system* Group I (Control): MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). * Group II (Experimental): MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system |
| MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). | Active comparator | Other: MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration systemMI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®). |
Who may qualify
- Ages
- 38 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women with primary or secondary infertility associated with diminished ovarian reserve, defined by ultrasound findings and laboratory parameters (FSH > 10 mIU/mL and estradiol < 60 pg/mL).
- Serum anti-Müllerian hormone (AMH) concentration < 1 ng/mL.
- Antral follicle count < 3-6 follicles per ovary.
- Anatomical preservation of both ovaries.
- Body mass index (BMI) between 24.5 and 30 kg/m².
Key exclusion criteria (14 listed)
- • Patients without a diagnosis of infertility.
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 |
|---|---|---|
| MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration systemMI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system | Other | MI oocytes were cultured exclusively in conventional IVM medium (VITROLIFE®)., MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes o |
Primary outcome
Proportion of Metaphase I Oocytes Reaching Metaphase II After In Vitro Cultureautologous exosomes obtained using the ExoSMarT® exosome filtration system
Time frame: 24-36 hours
This measure evaluates the number and proportion of metaphase I oocytes that progress to the metaphase II stage after 24-36 hours of in vitro culture in either conventional IVM medium or IVM medium supplemented with autologous exosomes. Maturation will be identified by the presence of the first polar body. Data will be summarized as a proportion of total metaphase I oocytes cultured.
Number of Mature Oocytes Fertilized After Intracytoplasmic Sperm Injection (ICSI)
Time frame: Approximately 18 hours after ICSI
This measure records the number and proportion of in vitro-matured metaphase II oocytes that demonstrate normal fertilization after ICSI, defined by the presence of two pronuclei under standard embryology laboratory criteria.
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 25 Nov 2025.
- Background: PubMed 16322539Mehlmann LM. Stops and starts in mammalian oocytes: recent advances in understanding the regulation of meiotic arrest and oocyte maturation. Reproduction. 2005 Dec;130(6):791-9. doi: 10.1530/rep.1.00793.
- Background: PubMed 21914669Chand AL, Legge M. Amino acid transport system L activity in developing mouse ovarian follicles. Hum Reprod. 2011 Nov;26(11):3102-8. doi: 10.1093/humrep/der298. Epub 2011 Sep 13.
- Background: PubMed 10976058Dupont S, Krust A, Gansmuller A, Dierich A, Chambon P, Mark M. Effect of single and compound knockouts of estrogen receptors alpha (ERalpha) and beta (ERbeta) on mouse reproductive phenotypes. Development. 2000 Oct;127(19):4277-91. doi: 10.1242/dev.127.19.4277.
- Background: PubMed 26073844Kiyama R, Wada-Kiyama Y. Estrogenic endocrine disruptors: Molecular mechanisms of action. Environ Int. 2015 Oct;83:11-40. doi: 10.1016/j.envint.2015.05.012. Epub 2015 Jun 11.
- Background: PubMed 25744083Coticchio G, Dal Canto M, Mignini Renzini M, Guglielmo MC, Brambillasca F, Turchi D, Novara PV, Fadini R. Oocyte maturation: gamete-somatic cells interactions, meiotic resumption, cytoskeletal dynamics and cytoplasmic reorganization. Hum Reprod Update. 2015 Jul-Aug;21(4):427-54. doi: 10.1093/humupd/dmv011. Epub 2015 Mar 4.
- Background: PubMed 39786528Esbert M, Reig A, Ballestros A, Seli E. Oocyte maturation defect in women undergoing IVF: contributing factors and effects on mature sibling oocyte outcomes. J Assist Reprod Genet. 2025 Mar;42(3):773-780. doi: 10.1007/s10815-024-03353-w. Epub 2025 Jan 9.
- Background: PubMed 39993495Coticchio G, Cimadomo D, Rienzi L. The daunting goal to rescue oocytes collected immature in conventional ovarian stimulation cycles. Fertil Steril. 2025 May;123(5):747-748. doi: 10.1016/j.fertnstert.2025.02.026. Epub 2025 Feb 22.
- Background: PubMed 40678344Navarro C, Torrecillas Cabrera P, Teppa Garran A. Comparative analysis of the use of autologous exosomes and platelet-derived growth factors in women with premature ovarian insufficiency and infertility: A prospective, randomized, observational, analytical study. Regen Ther. 2025 Jun 30;30:309-320. doi: 10.1016/j.reth.2025.06.007. eCollection 2025 Dec.
- Background: PubMed 2173353Tornell J, Billig H, Hillensjo T. Resumption of rat oocyte meiosis is paralleled by a decrease in guanosine 3',5'-cyclic monophosphate (cGMP) and is inhibited by microinjection of cGMP. Acta Physiol Scand. 1990 Jul;139(3):511-7. doi: 10.1111/j.1748-1716.1990.tb08953.x.
- Background: PubMed 4362350Cho WK, Stern S, Biggers JD. Inhibitory effect of dibutyryl cAMP on mouse oocyte maturation in vitro. J Exp Zool. 1974 Mar;187(3):383-6. doi: 10.1002/jez.1401870307. No abstract available.
- Background: PubMed 6154623Dekel N, Beers WH. Development of the rat oocyte in vitro: inhibition and induction of maturation in the presence or absence of the cumulus oophorus. Dev Biol. 1980 Mar 15;75(2):247-54. doi: 10.1016/0012-1606(80)90160-8. No abstract available.
- Background: PubMed 6189752Schultz RM, Montgomery RR, Belanoff JR. Regulation of mouse oocyte meiotic maturation: implication of a decrease in oocyte cAMP and protein dephosphorylation in commitment to resume meiosis. Dev Biol. 1983 Jun;97(2):264-73. doi: 10.1016/0012-1606(83)90085-4.
- Individual participant dataSharing planned: No. Not but the individual participant data (IPD) from this study will be available to other qualified researchers upon reasonable request. Data sharing will be granted after a formal email request specifying the investigator's identity, institutional affiliation, and research objective. Access will be provided only for scientifically justified purposes, in compliance with confidentiality agreements and ethical standards protecting participant privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI oocytes were cultured in conventional IVM medium supplemented with 10 µg of autologous exosomes obtained using the ExoSMarT® exosome filtration system in people with Diminished Ovarian Reserve, run by Biotech Fertility C.A. at 1 site in Venezuela.
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 13 inclusion and 14 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 25 Nov 2025. 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 Venezuela. 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?
Proportion of Metaphase I Oocytes Reaching Metaphase II After In Vitro Cultureautologous exosomes obtained using the ExoSMarT® exosome filtration system (time frame: 24-36 hours). 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 NCT07249411, which also lists 16 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 25 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.