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

NCT01071148 | Completed

• 2 other identifiers: EMR200061-5022008-002840-41
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Infertility; Gonal-f; Pergoveris; Luveris

Outcome Measures

Primary Outcomes (1)

• Cumulative ongoing pregnancy rate within one year of starting the trial in the total trial population

  Ongoing pregnancy is defined as the existence of at least one ultra-sonographically-confirmed gestational sac in the uterus, with foetal heart activity

  10 ± 2 weeks after hCG administration

Secondary Outcomes (10)

• Number of mature follicles of ≥18 mm in size

  7 days before hCG administration till the day of hCG administration i.e.day (-)7 - 0

• Number of oocytes retrieved

  Day 2

• Fertilisation rate

  Day 3

• Positive pregnancy test per cycle and cumulatively

  16 days post hCG administration

• Cumulative clinical pregnancy rate within one year of starting the trial

  5 weeks ± 2 weeks after hCG administration

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Norway: collaborator

Study Sites (1)

Klinikk Hausken

Haugesund, 5531, Norway

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Viveka Åberg, MD

  Merck Serono Norway

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 5, 2014

Record last verified: 2014-05

Locations

NO (1)