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Ovarian Stimulation Single Injection Elonva (OSSIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414737
Recruitment Status : Completed
First Posted : April 13, 2015
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
Flinders University
Information provided by (Responsible Party):
Professor Kelton Tremellen, Flinders Fertility

Brief Summary:
We would like to propose that it may be possible to use a solitary dose of Elonva (corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of women undergoing IVF, assuming that it is possible that "coasting" (withholding short acting rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a significant number of mature oocytes being produced and an acceptable pregnancy rate.

Condition or disease Intervention/treatment Phase
Infertility Drug: corifollitrophin alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovarian Stimulation Single Injection Elonva- The OSSIE Study
Study Start Date : February 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: corifollitrophin alfa
corifollitrophin alfa used as COH stimulant in IVF
Drug: corifollitrophin alfa
use of a single dose of corifollitrophin alfa to provide adequate controlled ovarian hyperstimulation during IVF treatment
Other Name: Elonva




Primary Outcome Measures :
  1. Oocyte maturity - number of mature oocytes (metaphase II oocytes) retrieved in IVF cycle [ Time Frame: IVF cycle (2 weeks approximately) ]
    number of mature oocytes (metaphase II oocytes) retrieved in IVF cycle


Other Outcome Measures:
  1. cryopreservation of embryos - number of good quality embryos available for cryopreservation [ Time Frame: IVF cycle ]
    number of good quality embryos available for cryopreservation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing a GnRH antagonist cycle of IVF as part of their personal fertility treatment
  • Eligible for the use of the 150 mcg dose of Elonva according to Australian PBS requirements (weight > 60 kg, antral follicle count < 20)
  • Intention of undergoing a fresh embryo transfer.
  • No major sperm quality issues (ejaculate sperm concentration > 5 million/ ml, motility > 25% neat sample). ICSI for the indication of poor morphology would be acceptable for trial enrollment.
  • Maternal age 18-37 years inclusive.

Exclusion Criteria:

  • Low ovarian reserve (antral follicle count 2-10 mm < 7, early follicular phase FSH > 10 IU/L, < 4 oocytes prior IVF cycle on a dose of rFSH > 150 IU).
  • Ovarian pathology (PCOS, ovarian cyst, endometrioma, poor trans-vaginal ultrasound ovary access).
  • 2 or more previous cycles of IVF (stimulated cycles) in which a live birth pregnancy did not result, or one prior stimulated cycle of IVF and 2 or more frozen embryo transfer cycles without a live birth outcome (possible implantation failure).
  • Significant pelvic pathology likely to impair embryo implantation (fibroids, polyps, uterine septum, hydrosalpinx).
  • Intention to freeze all embryos with nil fresh transfer (pre-implantation genetic screening, oncology fertility preservation).
  • Known renal impairment
  • Use of a long down regulation or "flare" IVF protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414737


Locations
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Australia, South Australia
Flinders Fertility
Bedford Park, South Australia, Australia, 5042
Sponsors and Collaborators
Flinders Fertility
Flinders University
Investigators
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Principal Investigator: Kelton Tremellen, MD PhD Flinders University
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Responsible Party: Professor Kelton Tremellen, Professor of Reproductive Medicine, Flinders Fertility
ClinicalTrials.gov Identifier: NCT02414737    
Other Study ID Numbers: AU/1/2 C8B110
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female