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

NCT02606500 | Completed Phase 4 Results

• 1 other identifier: Merck-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• Number of Oocytes Retrieved Per Patient

  Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group

  1 month

• Number of Mature Oocytes

  Number of mature oocytes obtained was compared between groups

  1 month

• Number of Fertilized Oocytes

  1 month

• Number of Frozen Embryos

  1 month

• Biochemical Pregnancy Rate

  1 year

Secondary Outcomes (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

  12 months

Study Arms (2)

Elonva 150 mcg

EXPERIMENTAL

Elonva 150 mcg intramuscular daily obese

Drug: Elonva

Elonva 100 mcg

ACTIVE COMPARATOR

Elonva 100 mcg intramuscular daily normal weight

Drug: Elonva

Interventions

Elonva DRUG

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.

Elonva 100 mcg; Elonva 150 mcg

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• polycystic ovary syndrome, severely abnormal sperm parameters, and age \> 38 years

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Division of gynecology, Department of human reproduction

Ljubljana, 1000, Slovenia

Location

Related Publications (5)

• Burnik Papler T, Vrtacnik Bokal E, Maver A, Kopitar AN, Lovrecic L. Transcriptomic Analysis and Meta-Analysis of Human Granulosa and Cumulus Cells. PLoS One. 2015 Aug 27;10(8):e0136473. doi: 10.1371/journal.pone.0136473. eCollection 2015.

  PMID: 26313571 BACKGROUND

• Burnik Papler T, Vrtacnik Bokal E, Maver A, Lovrecic L. Specific gene expression differences in cumulus cells as potential biomarkers of pregnancy. Reprod Biomed Online. 2015 Apr;30(4):426-33. doi: 10.1016/j.rbmo.2014.12.011. Epub 2015 Jan 12.

  PMID: 25682305 BACKGROUND

• Burnik Papler T, Vrtacnik Bokal E, Lovrecic L, Kopitar AN, Maver A. No specific gene expression signature in human granulosa and cumulus cells for prediction of oocyte fertilisation and embryo implantation. PLoS One. 2015 Mar 13;10(3):e0115865. doi: 10.1371/journal.pone.0115865. eCollection 2015.

  PMID: 25769026 BACKGROUND

• Devjak R, Fon Tacer K, Juvan P, Virant Klun I, Rozman D, Vrtacnik Bokal E. Cumulus cells gene expression profiling in terms of oocyte maturity in controlled ovarian hyperstimulation using GnRH agonist or GnRH antagonist. PLoS One. 2012;7(10):e47106. doi: 10.1371/journal.pone.0047106. Epub 2012 Oct 17.

  PMID: 23082142 BACKGROUND

• Vrtacnik-Bokal E, Virant Klun I, Verdenik I. Follicular oestradiol and VEGF after GnRH antagonists or GnRH agonists in women with PCOS. Reprod Biomed Online. 2009 Jan;18(1):21-8. doi: 10.1016/s1472-6483(10)60420-8.

  PMID: 19146765 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Eda Vrtacnik Bokal
• Organization: University medical centre Ljubljana

eda.bokal@guest.arnes.si

+38615226060

Study Officials

• Eda Vrtacnik Bokal, professor

  Head of the department of Human reproduction

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Tanja Burnik Papler, MD; PhD

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 17, 2015
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-05

Locations

SL (1)