InfertilityIVM-DK 2-0NCT07894952
Implementing IVM for Fertility Treatment in Clinical Practice
A study testing In vitro maturation in people with Infertility, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
The ovarian reserve consists of a finite pool of follicles that gradually declines throughout a woman's reproductive life. During conventional IVF, exogenous gonadotropins are administered for 10-14 days to support the growth and maturation of multiple follicles, followed by induction of final oocyte maturation before… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- In vitro maturation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2027to 1 May 2029
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- BMI < 35
- ovaries deemed easily accessible for transvaginal ultrasound-guided aspiration
- Speak and understand danish
- Women with AMH ≥ 30 pmol/L OR ≤ 6 pmol/L OR women with other infertility diagnoses OR a previous incident of OHSS, can be offered to participate if they choose to do so after appropriate counselling.
Who cannot join
- Ovarian endometriomas or dermoid cysts
- Male semen quality necessitating testicular aspiration (TESA)
- Chronic disease including medicated heart-, lung-, thyroid-, rheumatic-, or gastrointestinal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janni V Jeppesen, PhD contact
Denmark1 site
Fertility Clinic, Department of Gynaecology and Obstetrics, Herlev/Gentofte Hospital
Herlev, Capital Region, 2730
Liv C Poulsen, Md, PhD, +45 61600041, liv.la.cour.poulsen@regionh.dk
Janni V Jeppesen, PhD, janni.vikkelsoe.jeppesen@regionh.dk
About this study
The ovarian reserve consists of a finite pool of follicles that gradually declines throughout a woman's reproductive life. During conventional IVF, exogenous gonadotropins are administered for 10-14 days to support the growth and maturation of multiple follicles, followed by induction of final oocyte maturation before oocyte retrieval.
In vitro maturation (IVM) offers an alternative approach in which immature oocytes are retrieved from small antral follicles and matured in the laboratory within 24-44 hours. IVM requires no or only minimal ovarian stimulation and may therefore reduce treatment burden, costs, side effects, and the risk of ovarian hyperstimulation syndrome (OHSS). Recent advances in the retrieval of oocytes from small antral follicles, together with improved understanding of the molecular mechanisms regulating human oocyte maturation, have renewed interest in IVM and improved its clinical potential.
The overall aim of this project is to implement and optimize IVM as a clinical fertility treatment in Denmark. Specifically, we aim to: (1) evaluate the clinical success rates of IVM compared with conventional IVF; (2) characterize molecular differences between in vivo- and in vitro-matured oocytes and resulting blastocysts, as well as between follicular cells from small antral and preovulatory follicles; and (3) use new insights into the regulation of human oocyte maturation to optimize IVM protocols and improve treatment outcomes. Ultimately, the project aims to establish IVM as a safe, effective, and less burdensome alternative to conventional IVF for selected patient groups.
Read the detailed description
The project consists of two complementary sub-studies conducted at the Fertility Clinic, Herlev \& Gentofte Hospital. The first is a prospective cohort study evaluating the clinical implementation and outcomes of in vitro maturation (IVM) compared with conventional IVF. The study will primarily include women with a high ovarian reserve and increased risk of ovarian hyperstimulation syndrome (OHSS), women with low ovarian reserve and expected poor response to conventional stimulation, as well as selected women with other infertility diagnoses.
Immature cumulus-oocyte complexes (COCs) will be retrieved from small antral follicles by transvaginal ultrasound-guided aspiration and matured in vitro for 36-44 hours in culture medium supplemented with FSH and LH. Mature MII oocytes will subsequently undergo ICSI and embryo culture to the blastocyst stage. Suitable blastocysts will undergo PGT-A, cryopreservation and subsequent frozen embryo transfer.
The second sub-study is a cross-over study in healthy volunteers designed to directly compare IVM and conventional IVF within the same woman. Each participant will undergo one IVM cycle and one standard stimulated IVF cycle, allowing paired comparison of oocytes, follicular cells, follicular fluid and resulting embryos. Oocytes will either be cryopreserved for molecular analyses or fertilized with donor sperm and cultured to the blastocyst stage.
A comprehensive molecular characterization will compare the IVM and IVF environments and assess potential differences in oocytes, follicular cells and embryo development. Analyses will include steroid profiling, LC-MS/MS-based proteomics, TGF-β family members, embryo ploidy, RNA sequencing and DNA methylation profiling. Together with time-lapse assessment of embryo development, these analyses will provide a detailed characterization of the molecular and developmental consequences of in vitro versus in vivo oocyte maturation.
Overall, the project combines clinical implementation with mechanistic studies to evaluate the efficacy and safety of IVM, identify molecular differences between IVM and conventional IVF, and generate knowledge that can be used to further optimize human IVM protocols.
- Conditions
- Infertility
- Being tested
- In vitro maturation
- Keywords
- In Vitro Maturation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro maturationOther
Immature cumulus-oocyte complexes (COCs) will be retrieved from small antral follicles by transvaginal ultrasound-guided aspiration and matured in vitro for 30-44 hours in culture medium supplemented with FSH and LH. Mature MII oocytes will subsequently undergo ICSI and embryo culture to the blastocyst stage. Suitable blastocysts will undergo PGT-A, cryopreservation and subsequent frozen embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred for IVF treatment | Experimental | In Vitro Maturation (IVM treatment) with aspiration of immature oocytes from small antral follicles and subsequent maturation of oocytes in the laboratory. Receives: Other: In vitro maturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of blastocyst per metaphase II oocyte
Measured: From enrollment to end freezing of eligible blastocysts, maximum 14 days
Secondary outcomes (9)
Number of oocytes
Measured: From enrollment to oocyte pick up, maximum 7 days
Number of MII oocytes
Measured: From enrollment to end of in vitro maturation, maximum 10 days
Ratio of MII oocyte per oocyte aspirated
Measured: From enrollment to end of in vitro maturation, maximum 10 days
Number of blastocysts
Measured: From enrollment to end freezing of eligible blastocysts, maximum 14 days
Aneuploidy rates
Rates of aneuploid blastocysts per biopsied blastocyst
Measured: From enrollment to analysis results from the PGT-A analysis, maximum 2 months
Positive hCG test
Serum-hCG measurement approximately 14 days after blastocyst transfer
Measured: From enrollment to hCG test approximately 14 days after blastocyst transfer
Clinical pregnancy rate
Ultrasonic pregnancy at 7-8 weeks of gestation
Measured: From enrollment to pregnancy ultrasound at 7-8 weeks of gestation
Live birth rate
Live birth following IVM treatment
Measured: From enrollment to birth of a living child
Complications necessitating hospitalization
Pain, infection or bleeding related to the oocyte pick up
Measured: From enrollment untill two weeks after oocyte pick up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Danmarks Frie Forskningsfond, Region Hovedstaden (Herlev/Gentofte Hospital)
- Responsible party
- Principal investigator, Pernille Fog Svendsen, Copenhagen University Hospital at Herlev
- Investigators
- Pernille F Svendsen, DmSC, Study chair, Department of Gynaecology and Obstetrics, Herlev/Gentofte Hospital, Copenhagen University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894952
- Sponsor's protocol ID
- H-26035194
- Other IDs
- 5333-00040A
- Acronym
- IVM-DK 2-0
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing IVM for Fertility Treatment in Clinical Practice
- ClinicalTrials.gov ID
- NCT07894952
- Acronym / sponsor ID
- IVM-DK 2-0 / H-26035194
- Conditions
- Infertility
- Keywords
- In Vitro Maturation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Danmarks Frie Forskningsfond, Region Hovedstaden (Herlev/Gentofte Hospital)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 26 Oct 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.
The ovarian reserve consists of a finite pool of follicles that gradually declines throughout a woman's reproductive life. During conventional IVF, exogenous gonadotropins are administered for 10-14 days to support the growth and maturation of multiple follicles, followed by induction of final oocyte maturation before oocyte retrieval.
In vitro maturation (IVM) offers an alternative approach in which immature oocytes are retrieved from small antral follicles and matured in the laboratory within 24-44 hours. IVM requires no or only minimal ovarian stimulation and may therefore reduce treatment burden, costs, side effects, and the risk of ovarian hyperstimulation syndrome (OHSS). Recent advances in the retrieval of oocytes from small antral follicles, together with improved understanding of the molecular mechanisms regulating human oocyte maturation, have renewed interest in IVM and improved its clinical potential.
The overall aim of this project is to implement and optimize IVM as a clinical fertility treatment in Denmark. Specifically, we aim to: (1) evaluate the clinical success rates of IVM compared with conventional IVF; (2) characterize molecular differences between in vivo- and in vitro-matured oocytes and resulting blastocysts, as well as between follicular cells from small antral and preovulatory follicles; and (3) use new insights into the regulation of human oocyte maturation to optimize IVM protocols and improve treatment outcomes. Ultimately, the project aims to establish IVM as a safe, effective, and less burdensome alternative to conventional IVF for selected patient groups.
Detailed description
The project consists of two complementary sub-studies conducted at the Fertility Clinic, Herlev \& Gentofte Hospital. The first is a prospective cohort study evaluating the clinical implementation and outcomes of in vitro maturation (IVM) compared with conventional IVF. The study will primarily include women with a high ovarian reserve and increased risk of ovarian hyperstimulation syndrome (OHSS), women with low ovarian reserve and expected poor response to conventional stimulation, as well as selected women with other infertility diagnoses.
Immature cumulus-oocyte complexes (COCs) will be retrieved from small antral follicles by transvaginal ultrasound-guided aspiration and matured in vitro for 36-44 hours in culture medium supplemented with FSH and LH. Mature MII oocytes will subsequently undergo ICSI and embryo culture to the blastocyst stage. Suitable blastocysts will undergo PGT-A, cryopreservation and subsequent frozen embryo transfer.
The second sub-study is a cross-over study in healthy volunteers designed to directly compare IVM and conventional IVF within the same woman. Each participant will undergo one IVM cycle and one standard stimulated IVF cycle, allowing paired comparison of oocytes, follicular cells, follicular fluid and resulting embryos. Oocytes will either be cryopreserved for molecular analyses or fertilized with donor sperm and cultured to the blastocyst stage.
A comprehensive molecular characterization will compare the IVM and IVF environments and assess potential differences in oocytes, follicular cells and embryo development. Analyses will include steroid profiling, LC-MS/MS-based proteomics, TGF-β family members, embryo ploidy, RNA sequencing and DNA methylation profiling. Together with time-lapse assessment of embryo development, these analyses will provide a detailed characterization of the molecular and developmental consequences of in vitro versus in vivo oocyte maturation.
Overall, the project combines clinical implementation with mechanistic studies to evaluate the efficacy and safety of IVM, identify molecular differences between IVM and conventional IVF, and generate knowledge that can be used to further optimize human IVM protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for IVF treatment | Experimental | Other: In vitro maturationIn Vitro Maturation (IVM treatment) with aspiration of immature oocytes from small antral follicles and subsequent maturation of oocytes in the laboratory. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years
- BMI < 35
- ovaries deemed easily accessible for transvaginal ultrasound-guided aspiration
- Speak and understand danish
- Women with AMH ≥ 30 pmol/L OR ≤ 6 pmol/L OR women with other infertility diagnoses OR a previous incident of OHSS, can be offered to participate if they choose to do so after appropriate counselling.
Key exclusion criteria (3 listed)
- Ovarian endometriomas or dermoid cysts
- Male semen quality necessitating testicular aspiration (TESA)
- Chronic disease including medicated heart-, lung-, thyroid-, rheumatic-, or gastrointestinal disease.
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 |
|---|---|---|
| In vitro maturationImmature cumulus-oocyte complexes (COCs) will be retrieved from small antral follicles by transvaginal ultrasound-guided aspiration and matured in vitro for 30-44 hours in culture medium supplemented with FSH and LH. Mature MII oocytes will subsequently undergo ICSI and embryo culture to the blastocyst stage. Suitable blastocysts will undergo PGT-A, cryopreservation and subsequent frozen embryo transfer. | Other | Patients referred for IVF treatment |
Primary outcome
Ratio of blastocyst per metaphase II oocyte
Time frame: From enrollment to end freezing of eligible blastocysts, maximum 14 days
9 secondary outcomes
Number of oocytes
Time frame: From enrollment to oocyte pick up, maximum 7 days
Number of MII oocytes
Time frame: From enrollment to end of in vitro maturation, maximum 10 days
Ratio of MII oocyte per oocyte aspirated
Time frame: From enrollment to end of in vitro maturation, maximum 10 days
Number of blastocysts
Time frame: From enrollment to end freezing of eligible blastocysts, maximum 14 days
Aneuploidy rates
Time frame: From enrollment to analysis results from the PGT-A analysis, maximum 2 months
Positive hCG test
Time frame: From enrollment to hCG test approximately 14 days after blastocyst transfer
Clinical pregnancy rate
Time frame: From enrollment to pregnancy ultrasound at 7-8 weeks of gestation
Live birth rate
Time frame: From enrollment to birth of a living child
Complications necessitating hospitalization
Time frame: From enrollment untill two weeks after oocyte pick up.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Janni V Jeppesen, PhD contact
Pernille F Svendsen, DmSC study chair
Department of Gynaecology and Obstetrics, Herlev/Gentofte Hospital, Copenhagen University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In vitro maturation in people with Infertility, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 5 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 26 Oct 2026. 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 Denmark. 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?
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 Liv C Poulsen, MD, PhD (+45 61600041, liv.la.cour.poulsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of blastocyst per metaphase II oocyte (time frame: From enrollment to end freezing of eligible blastocysts, maximum 14 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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.