An interventional study of In vitro maturation in Infertility, sponsored by Copenhagen University Hospital, Hvidovre. Not yet recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Copenhagen University Hospital, Hvidovre · Not applicable, Interventional, and Treatment
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.
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.
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 155 is above the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Copenhagen University Hospital, Hvidovre is the lead sponsor of 78 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
In Vitro Maturation (IVM treatment) with aspiration of immature oocytes from small antral follicles and subsequent maturation of oocytes in the laboratory.
Other: In vitro maturation
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.
Ratio of blastocyst per metaphase II oocyte
Time frame: From enrollment to end freezing of eligible blastocysts, maximum 14 days
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
Rates of aneuploid blastocysts per biopsied blastocyst
Time frame: 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
Time frame: From enrollment to hCG test approximately 14 days after blastocyst transfer
Clinical pregnancy rate
Ultrasonic pregnancy at 7-8 weeks of gestation
Time frame: From enrollment to pregnancy ultrasound at 7-8 weeks of gestation
Live birth rate
Live birth following IVM treatment
Time frame: From enrollment to birth of a living child
Complications necessitating hospitalization
Pain, infection or bleeding related to the oocyte pick up
Time frame: From enrollment untill two weeks after oocyte pick up.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for May 2029, 28 months later.
Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 28 months is above that.
Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Hvidovre