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

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Elonva Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Elonva 150 mcg
Elonva 150 mcg intramuscular daily obese
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.


Active Comparator: Elonva 100 mcg
Elonva 100 mcg intramuscular daily normal weight
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.





Primary Outcome Measures :
  1. 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

  2. Number of Mature Oocytes [ Time Frame: 1 month ]
    Number of mature oocytes obtained was compared between groups

  3. Number of Fertilized Oocytes [ Time Frame: 1 month ]
  4. Number of Frozen Embryos [ Time Frame: 1 month ]
  5. Biochemical Pregnancy Rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02606500


Locations
Layout table for location information
Slovenia
Division of gynecology, Department of human reproduction
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Chair: Eda Vrtacnik Bokal, professor Head of the department of Human reproduction

Publications:
Layout table for additonal information
Responsible Party: Tanja Burnik Papler, Principal investigator Tanja Burnik Papler, MD; PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02606500     History of Changes
Other Study ID Numbers: Merck-01
First Posted: November 17, 2015    Key Record Dates
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018
Last Verified: May 2018