A Phase IV, Prospective, Observational, Open Label, Single Centre Cohort Trial to be Conducted in Norway During One Year to Assess the Cumulative Pregnancy Rate in a New Series of In-vitro Fertilization (IVF) Treatment Cycles Following Three or More Previous IVF Treatment Cycles Without Live Birth

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Norway
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01071148
First received: February 18, 2010
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The primary objective of this observational study is to assess the cumulative rate of ongoing pregnancy at 10 ±2 weeks after hCG administration in a new series of IVF-treatment cycles in a total of 176 subjects, who have undergone three or more previous IVF-treatment cycles without live birth. Secondary objectives include subgroup analysis on the effect of age on the likelihood of pregnancy at 10 ±2 weeks after hCG administration in a new series of IVF-treatment cycles in patients < 35 years and ≥ 35 years, who have undergone three or more previous IVF-treatment cycles without live birth.

The information obtained from this trial will be helpful for subjects who are considering further IVF treatments and for IVF centres, as well as for the formulation of governmental policies regarding healthcare reimbursement in Norway.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Prospective, Observational, Open Label, Single Centre Cohort Trial to be Conducted in Norway During One Year to Assess the Cumulative Pregnancy Rate in a New Series of In-vitro Fertilization (IVF) Treatment Cycles Following Three or More Previous IVF Treatment Cycles Without Live Birth.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Cumulative ongoing pregnancy rate within one year of starting the trial in the total trial population [ Time Frame: 10 ± 2 weeks after hCG administration ] [ Designated as safety issue: No ]
    Ongoing pregnancy is defined as the existence of at least one ultra-sonographically-confirmed gestational sac in the uterus, with foetal heart activity


Secondary Outcome Measures:
  • Number of mature follicles of ≥18 mm in size [ Time Frame: 7 days before hCG administration till the day of hCG administration i.e.day (-)7 - 0 ] [ Designated as safety issue: No ]
  • Number of oocytes retrieved [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Fertilisation rate [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Positive pregnancy test per cycle and cumulatively [ Time Frame: 16 days post hCG administration ] [ Designated as safety issue: No ]
  • Cumulative clinical pregnancy rate within one year of starting the trial [ Time Frame: 5 weeks ± 2 weeks after hCG administration ] [ Designated as safety issue: No ]
  • Clinical pregnancy rate per first, second and third new IVF-cycle [ Time Frame: 5 weeks ± 2 weeks after hCG administration ] [ Designated as safety issue: No ]
  • Ongoing pregnancy rate per first, second and third new IVF-cycle [ Time Frame: 10 weeks ± 2 weeks after hCG administration ] [ Designated as safety issue: No ]
  • Cumulative live birth rate(if available) [ Time Frame: Follow-up period of 1 year ] [ Designated as safety issue: No ]
  • Cumulative ongoing pregnancy rate within one year of starting the trial in subjects aged < 35 years and ≥ 35 years [ Time Frame: 10 ± 2 weeks after hCG administration ] [ Designated as safety issue: No ]
    Ongoing pregnancy is defined as the existence of at least one ultra-sonographically-confirmed gestational sac in the uterus, with foetal heart activity

  • Ongoing pregnancy rate per IVF-treatment cycle within one year of starting the trial in the total trial population and in subgroup analysis in subjects aged < 35 years and ≥ 35 years [ Time Frame: 10 ±2 weeks after hCG administration ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subgroup 1: Age < 35 years
Subjects who have experienced infertility and justifying IVF/ET treatment will be administered either Gonal-f or Pergoveris or Gonal-f and Luveris as per the discretion of the investigator.
Subgroup 2: 42 > Age ≥ 35 years
Subjects who have experienced infertility and justifying IVF/ET treatment will be administered either Gonal-f or Pergoveris or Gonal-f and Luveris as per the discretion of the investigator.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of 176 subjects justifying IVF therapy at a single IVF centre in Norway will be recruited into this trial. Subjects must have been treated with three or more previous IVF-cycles without live birth.

Criteria

Inclusion Criteria:

  • Infertility justifying IVF/ET treatment
  • The decision of treating subject with GONAL-f or Pergoveris or GONAL-f and Luveris is made before considering the subject for the trial.
  • Age between 18th and 42nd birthday at the screening visit.
  • Have undergone three or more previous IVF-treatment cycles that did not result in live birth.
  • Have good general health that allows IVF therapy
  • Have a male partner with semen analysis, performed within 12 months prior to screening, that was considered adequate to proceed with regular insemination or ICSI according to the centre's standard practice
  • At least one ovary present
  • Have given written informed consent

Exclusion Criteria:

  • FSH > 12 IU/L
  • Body mass index (BMI) > 40 kg/m2
  • Pre-treatment antral follicle count [follicles ≥2mm - <11mm]) < 4
  • Previous IVF attempts with no follicle development.
  • Any contraindication for the use of GONAL-f or Pergoveris or Luveris (refer to SPC)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071148

Locations
Norway
Klinikk Hausken
Haugesund, Norway, 5531
Sponsors and Collaborators
Merck KGaA
Merck Serono Norway
Investigators
Study Director: Viveka Åberg, MD Merck Serono Norway
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01071148     History of Changes
Obsolete Identifiers: NCT00893204
Other Study ID Numbers: EMR200061-502, 2008-002840-41
Study First Received: February 18, 2010
Last Updated: May 2, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Merck KGaA:
Infertility
Gonal-f
Pergoveris
Luveris

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014