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

NCT05370794 | Unknown

• 1 other identifier: 2021-IVM-FSHhCG
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

In Vitro Maturation of Oocytes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fertilization rate

  the presence of 2 pronuclei is assessed between 18-20 hours after ICSI

• morphologic parameters describing embryo quality per fertilized oocyte

  embryo developmental assessment is performed 3 days after ICSI

• utilization rate

  utilization rate will be established 3 days after ICSI

Study Arms (2)

standard IVM: urinary purified gonadotropins (uFSH and uhCG)

uhCG = Pregnyl®, 5000IU/ vial, Organon-Merck: final concentration 100mIU/ml + uFSH = Menopur® 75mIU/ml, Ferring: final concentration 75mIU/ml. Administered during 30h of in vitro maturation culture

Experimental IVM: recombinant gonadotropins (rFSH and rhCG)

rhCG= Ovitrelle®, 250g/0.5ml = 26000IU/ml, Merck-Serono : final concentration 100mIU/ml + rFSH = Gonal F®, 300IU/0.5ml, Merck-Serono: final concentration 75mIU/ml. Administered during 30h of in vitro maturation culture

Drug: rhCG= Ovitrelle®, 250g/0.5ml = 26000IU/ml, Merck-Serono; Drug: rFSH = Gonal F®, 300IU/0.5ml, Merck-Serono

Interventions

rhCG= Ovitrelle®, 250g/0.5ml = 26000IU/ml, Merck-Serono DRUG

recombinant hCG

Experimental IVM: recombinant gonadotropins (rFSH and rhCG)

rFSH = Gonal F®, 300IU/0.5ml, Merck-Serono DRUG

recombinant FSH

Experimental IVM: recombinant gonadotropins (rFSH and rhCG)

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

infertility patients

You may qualify if:

• PCO(S) patients
• Anti-Mullerian Hormone ≥ 3.6 ng/mL
• Basal Antral Follicle Count ≥ 20
• All ranks of trial

You may not qualify if:

• Surgically obtained semen sample
• Grade 3 or 4 endometriosis, minor or major uterine abnormalities
• Preimplantation Genetic Testing
• Priming with Letrozole

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Related Publications (6)

• 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.

  PMID: 31111879 BACKGROUND

• 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.

  PMID: 34050448 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2007.02.021. Epub 2007 May 24.

  PMID: 17524398 BACKGROUND

• 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. doi: 10.2147/ijwh.s4729.

  PMID: 21072289 BACKGROUND

• 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. doi: 10.1016/s1472-6483(10)60163-0.

  PMID: 19778474 BACKGROUND

• 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.

  PMID: 29044421 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

spent medium after IVM, cumulus cells after IVM

Study Officials

• Michel De Vos, MD,PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Segers, PhD

CONTACT

+3224776690; ingrid.segers@uzbrussel.be

Elsie Nulens

CONTACT

+3224776690; elsie.nulens@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 12, 2022
• Study Start: April 19, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)