Study Results
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Basic Information
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COMPLETED
1351 participants
OBSERVATIONAL
2013-01-31
2018-12-31
Brief Summary
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Detailed Description
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Hence, the aim of this study is to investigate the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon). The investigators hypothesize that there are differences in morphokinetic behavior of embryos within the different stimulation protocols.
A total of 742 embryos from 215 different patients suffering from infertility undergoing ovarian stimulation with Elonva and a total of 5148 embryos from 1136 patients undergoing ovarian stimulation with Puregon will be retrospectively analyzed. To exclude environmental factors the evaluation will distinguish between embryos cultured under 21% oxygen and embryos with reduced oxygen conditions (5% oxygen) in the embryoscope. Groups will be age and BMI matched.
All women included in the study underwent GnRH (Gonadotropin-releasing hormone) antagonist protocol controlled ovarian hyperstimulation. Patients received recombinant human follicle-stimulating hormone (Elonva; MSD Sharp \&Dohme GMBH, Puregon; MSD Sharp \& Dohme GMBH). ELONVA was administered for 7 days with subsequent administration of Puregon (MSD Sharp \& Dohme GMBH) in case of further need of stimulation. Puregon was administered for 8-10 days with dosage adaption according to age, weight, serum anti-mullerian hormone (sAMH) concentration, and hormonal status. Trans-vaginal sonography was performed after 5 days of stimulation, followed by every second day until the day of oocyte retrieval. Ultrasonographical measurement was performed using a RIC 5-9-D 4D intravaginal probe of a GE Voluson E8 BT09 ultrasound machine (both from GE Healthcare Austria GmbH). GnRH antagonist (Cetrotide, Merck KGaA) was injected to avoid premature ovulation. Triggering was initiated 35 h before oocyte retrieval, administered with 5000-10,000 IU human chorionic gonadotropin (hCG) subcutaneously (Pregnyl, N.V. Organon), with dosage adaption according to body weight of the patient.
Follicles larger than 10 mm in diameter were aspirated under sedation (Propofol, Fresenius Kabi Austria GmbH; Rapifen, Janssen-Cilag Pharma GmbH) and transvaginal ultrasound guidance (GE Healthcare Austria GmbH). Follicular fluid (FF) were examined for oocytes under constant conditions of 37 °C in an IVF workstation L24E with heating stage (K-SYSTEMS Kivex Biotec A/S). Intracytoplasmic sperm injection (ICSI) was performed on all metaphase II (MII) oocytes 4-5h after oocyte retrieval according to our standard operating procedure in both groups of patients.
After oocyte retrieval and fertilization, oocytes were cultivated in universal culture medium (Gynemed Medizinprodukte GmbH \& Co. KG, Germany). After 14-16 h, fertilization check was performed. All normal fertilized embryos with two pronuclei (PN) were then cultured using Embryoslide dishes in Embryoscope® time-lapse incubator (both Vitrolife AB, Sweden). With the built-in camera and microscope, images of the developing embryo were taken every 15 min in seven different layers. Definition of morphokinetic parameters was performed according to the criteria proposed by Ciray et al. and was analyzed with software developed for time-lapse image analysis (Embryoviewer® software; Vitrolife AB, Sweden).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ELONVA
Patients stimulated with Elonva
ELONVA
Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
PUREGON
Patients stimulated with Puregon
PUREGON
Puregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Interventions
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ELONVA
Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
PUREGON
Puregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Eligibility Criteria
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Inclusion Criteria
* BMI: 19-29.9
* Primary or secondary infertility
* Ovarian stimulation with Elonva/Puregon
* Embryos cultured in embryoscope
Exclusion Criteria
* genetic testing
18 Years
42 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Kinderwunsch Institut GmbH
OTHER
Responsible Party
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Principal Investigators
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Michael Schenk, Dr.
Role: PRINCIPAL_INVESTIGATOR
Das Kinderwunsch Institut Schenkg GmbH
Locations
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Das Kinderwunsch Institut Schenk GmbH
Dobl, Styria, Austria
Countries
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References
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Gryshchenko MG, Pravdyuk AI, Parashchyuk VY. Analysis of factors influencing morphokinetic characteristics of embryos in ART cycles. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:6-8. doi: 10.3109/09513590.2014.945763.
Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.
Chawla M, Fakih M, Shunnar A, Bayram A, Hellani A, Perumal V, Divakaran J, Budak E. Morphokinetic analysis of cleavage stage embryos and its relationship to aneuploidy in a retrospective time-lapse imaging study. J Assist Reprod Genet. 2015 Jan;32(1):69-75. doi: 10.1007/s10815-014-0372-3. Epub 2014 Nov 14.
Armstrong S, Vail A, Mastenbroek S, Jordan V, Farquhar C. Time-lapse in the IVF-lab: how should we assess potential benefit? Hum Reprod. 2015 Jan;30(1):3-8. doi: 10.1093/humrep/deu250. Epub 2014 Oct 14.
Milewski R, Kuc P, Kuczynska A, Stankiewicz B, Lukaszuk K, Kuczynski W. A predictive model for blastocyst formation based on morphokinetic parameters in time-lapse monitoring of embryo development. J Assist Reprod Genet. 2015 Apr;32(4):571-9. doi: 10.1007/s10815-015-0440-3. Epub 2015 Feb 18.
VerMilyea MD, Tan L, Anthony JT, Conaghan J, Ivani K, Gvakharia M, Boostanfar R, Baker VL, Suraj V, Chen AA, Mainigi M, Coutifaris C, Shen S. Computer-automated time-lapse analysis results correlate with embryo implantation and clinical pregnancy: a blinded, multi-centre study. Reprod Biomed Online. 2014 Dec;29(6):729-36. doi: 10.1016/j.rbmo.2014.09.005. Epub 2014 Sep 21.
Other Identifiers
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FRED001
Identifier Type: -
Identifier Source: org_study_id
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