In Vitro Maturation of Oocytes Clinical Trial
— IVM-FSHhCGOfficial title:
Is in Vitro Maturation of Oocytes Influenced by the Origin of Gonadotropins Used in Maturation Medium: is There a Difference in Efficiency When Using Urinary Versus Recombinant Produced Follicle Stimulating Hormone and Human Chorionic Gonadotropin
Standard IVM currently contains urinary purified hormones which might contain contaminants possibly affecting maturation of embryo development. The investigators will test if the efficiency in terms of oocyte maturation after IVM of recombinant (without contaminants) is equivalent to urinary gonadotropins. Urinary and recombinant FSH and hCG will be used in equivalent bioactivity as measured in IU/ml and specified by the manufacturer. Sibling oocytes of the patient will be subjected to IVM medium containing urinary or recombinant gonadotropins. Oocyte maturation is the primary outcome, however, fertilization rate and preimplantation embryo development will be investigated.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - PCO(S) patients - Anti-Mullerian Hormone = 3.6 ng/mL - Basal Antral Follicle Count = 20 - All ranks of trial Exclusion Criteria: - Surgically obtained semen sample - Grade 3 or 4 endometriosis, minor or major uterine abnormalities - Preimplantation Genetic Testing - Priming with Letrozole |
Country | Name | City | State |
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Belgium | UZ Brussel | Brussels |
Lead Sponsor | Collaborator |
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Universitair Ziekenhuis Brussel |
Belgium,
Bassett R, Lispi M, Ceccarelli D, Grimaldi L, Mancinelli M, Martelli F, Van Dorsselaer A. Analytical identification of additional impurities in urinary-derived gonadotrophins. Reprod Biomed Online. 2009 Sep;19(3):300-13. — View Citation
Cadenas J, Nikiforov D, Pors SE, Zuniga LA, Wakimoto Y, Ghezelayagh Z, Mamsen LS, Kristensen SG, Andersen CY. A threshold concentration of FSH is needed during IVM of ex vivo collected human oocytes. J Assist Reprod Genet. 2021 Jun;38(6):1341-1348. doi: 10.1007/s10815-021-02244-8. Epub 2021 May 28. — View Citation
Ge HS, Huang XF, Zhang W, Zhao JZ, Lin JJ, Zhou W. Exposure to human chorionic gonadotropin during in vitro maturation does not improve the maturation rate and developmental potential of immature oocytes from patients with polycystic ovary syndrome. Fertil Steril. 2008 Jan;89(1):98-103. Epub 2007 May 24. — View Citation
Ho VNA, Braam SC, Pham TD, Mol BW, Vuong LN. The effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilization in women with a high antral follicle count. Hum Reprod. 2019 Jun 4;34(6):1055-1064. doi: 10.1093/humrep/dez060. — View Citation
Nahuis M, van der Veen F, Oosterhuis J, Mol BW, Hompes P, van Wely M. Review of the safety, efficacy, costs and patient acceptability of recombinant follicle-stimulating hormone for injection in assisting ovulation induction in infertile women. Int J Womens Health. 2010 Aug 9;1:205-11. — View Citation
Riccetti L, Klett D, Ayoub MA, Boulo T, Pignatti E, Tagliavini S, Varani M, Trenti T, Nicoli A, Capodanno F, La Sala GB, Reiter E, Simoni M, Casarini L. Heterogeneous hCG and hMG commercial preparations result in different intracellular signalling but induce a similar long-term progesterone response in vitro. Mol Hum Reprod. 2017 Oct 1;23(10):685-697. doi: 10.1093/molehr/gax047. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | oocyte maturation | the ability of the oocyte to extrude the first polar body | oocyte maturation is assessed after 30 hours of in vitro maturation | |
Secondary | Fertilization rate | the ability of the oocyte to ba activated and form pronuclei | the presence of 2 pronuclei is assessed between 18-20 hours after ICSI | |
Secondary | morphologic parameters describing embryo quality per fertilized oocyte | embryo developmental potential as estimated by morphological characteristics: embryos with 6 cells or more, less than 20% fragmentation, cell size according to division pattern and the absence of multinucleated blastomeres are considered as good quality embryos. As secondary parameters, the presence of vacuoles or granulation in the majority of blastomeres will exclude the embryo from the 'good quality' group regardless of the earlier mentioned parameters. | embryo developmental assessment is performed 3 days after ICSI | |
Secondary | utilization rate | the embryos of sufficient quality to be vitrified for a deferred embryo transfer | utilization rate will be established 3 days after ICSI |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
NCT04285892 -
Embryo Developmental Potential in a Novel 2-step IVM System
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N/A |