Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

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: NCT02606500
Recruitment Status : Completed
First Posted : November 17, 2015
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanja Burnik Papler, University Medical Centre Ljubljana

Tracking Information
First Submitted Date  ICMJE November 6, 2015
First Posted Date  ICMJE November 17, 2015
Results First Submitted Date  ICMJE August 30, 2017
Results First Posted Date  ICMJE November 26, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Number of Oocytes Retrieved Per Patient [ Time Frame: 1 month ]
    Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
  • Number of Mature Oocytes [ Time Frame: 1 month ]
    Number of mature oocytes obtained was compared between groups
  • Number of Fertilized Oocytes [ Time Frame: 1 month ]
  • Number of Frozen Embryos [ Time Frame: 1 month ]
  • Biochemical Pregnancy Rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Number of oocytes retrieved and pregnancies achieved when corifollitropin alpha is used for ovarian stimulation in obese women [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT02606500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level [ Time Frame: 12 months ]
Expression of some genes that were proposed as biomarkers of oocyte quality was analysed in CC using real-time PCR. Relative expression values of genes were compared between mature oocytes derived from obese women and mature oocytes derived from normal weighing women.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Analysis of genes that were proposed as biomarkers of oocyte quality to determine effect of corifollitropin alpha on oocyte quality on molecular level [ Time Frame: 12 months ]
Expression of genes that were proposed as biomarkers of oocyte quality will be analysed using real-time PCR. Relative expression values of genes will be compared between oocytes derived from obese women and oocytes derived from normal weighing women.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Official Title  ICMJE Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Brief Summary The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.
Detailed Description

The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60 kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women with a body weight > 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is administered for COH. These two protocols are comparable in safety and efficacy of follicular stimulation.

On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa in obese women (BMI>30 kg/m2) is lacking.

Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC is necessary for the development of mature and quality oocytes. It has been proposed, that analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2 (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2), glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte maturity and developmental potential.

The effect of Corifollitropin alfa on expression of these genes however, is unknown.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Elonva

20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups.

The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years.

Study Arms  ICMJE
  • Experimental: Elonva 150 mcg
    Elonva 150 mcg intramuscular daily obese
    Intervention: Drug: Elonva
  • Active Comparator: Elonva 100 mcg
    Elonva 100 mcg intramuscular daily normal weight
    Intervention: Drug: Elonva
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
40
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI > 30 kg/m2
  • BMI 18.5-24.9 kg/m2

Exclusion Criteria:

  • polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02606500
Other Study ID Numbers  ICMJE Merck-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tanja Burnik Papler, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Chair: Eda Vrtacnik Bokal, professor Head of the department of Human reproduction
PRS Account University Medical Centre Ljubljana
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP