Safety and Efficacy of a Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing IVF (CONSORT in ART)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00249834
First received: November 4, 2005
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

CONSORT = Clinical validation of the ART treatment guidelines, which determine the optimal dose of r hFSH based on subject baseline characteristics/predictors of ovarian response.

Phase IIIb/IV, open-label, multi-centre, multi-regional study. Subject will first be treated with a GnRH agonist according to centre's standard practice (no depot formulation will be allowed). Down-regulation is to be confirmed by E2 levels and/or US scan depending on centre's standard practice. Subject will then start r-hFSH treatment (Gonal-f® Prefilled Pen) at a pre-defined, fixed dose according to the provided ART treatment guidelines. Dose adjustment will be allowed strictly in case of risk of OHSS. Once follicular development is adequate (ie. at least 1 follicle ≥ 18mm and 2 follicles ≥ 16mm), a single injection of 250 mcg of r-hCG (Ovid[t]rel [le]®) will be administered.

Ovum Pick Up (OPU), in vitro fertilisation (IVF) and embryo transfer (ET) will be performed as per centre's standard practice.

A post-treatment safety visit will be performed for all subjects on days 15-20 post-hCG.


Condition Intervention Phase
Infertility
Other: CONSORT calculator
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of oocytes retrieved,total dose of r-hFSH used,number of stimulation days,cycle cancellation rate,number of subjects needing dose adjustment,mean daily r-hFSH dose,implantation rate,total,clinical and multiple pregnancy rates. [ Time Frame: During ovum pick-up procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total dose of r-hFSH used,number of stimulation days,cycle cancellation rate,number of subjects needing dose adjustment,mean daily r-hFSH dose,implantation rate,total,clinical and multiple pregnancy rates.. [ Time Frame: see above mentioned timeframes for each measure ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: September 2004
Study Completion Date: March 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: CONSORT calculator
The subject's Age, Body Mass Index (kg/m2), Number of follicles < 11 mm on a baseline ultrasound scan, Serum FSH level in the early follicular phase of a menstrual cycle were entered in an algorithm (CONSORT calculator), which then calculated the optimal fixed starting dose of r-hFSH for each subject according to her individual characteristics.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Be an infertile subject justifying an IVF/ET treatment.
  • Have a male partner with semen analysis within the past six months prior to study entry considered adequate to proceed with regular insemination or ICSI according to the centre's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.
  • Be between her 18th and 35th birthday (35 not included).
  • Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.
  • Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:
  • FSH ≤ 12IU/L, and
  • E2 within centre's local normal laboratory range values.
  • Presence of both ovaries.
  • Have a uterine cavity without abnormalities, which, in the investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
  • Have a negative cervical PAP test within the last 6 months prior to study entry.
  • Have at least one wash-out cycle (defined as ≥ 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting GnRH agonist therapy.
  • Have a negative pregnancy test prior to beginning GnRH agonist therapy.
  • Be willing and able to comply with the protocol for the duration of the study. Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.

Exclusion Criteria:

  • Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as ≤5 mature follicles and/or ≤3 oocytes collected in any previous IVF cycle or hyper response, defined as ≥25 oocytes retrieved.
  • Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
  • Had previous severe ovarian hyperstimulation syndrome (OHSS).
  • A body mass index (BMI) >30 kg/m2 where the BMI is calculated according to the following formula:
  • Any contraindication to being pregnant and/or carrying a pregnancy to term.
  • Extra-uterine pregnancy within the last 3 months.
  • History of 3 or more miscarriages (early or late miscarriages) due to any cause.
  • Tumours of the hypothalamus and pituitary gland.
  • Ovarian enlargement or cyst of unknown aetiology.
  • Ovarian, uterine or mammary cancer.
  • A clinically significant systemic disease.
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
  • Abnormal gynaecological bleeding of undetermined origin.
  • Known allergy or hypersensitivity to human gonadotrophin preparations.
  • Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.
  • Entered previously into this study or simultaneous participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249834

Locations
France
Medical Information
Paris, France
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Christoph Keck, M.D. Sponsor GmbH
  More Information

Additional Information:
Publications:
Responsible Party: Shelly Bustion, Merck Serono International S.A., Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT00249834     History of Changes
Other Study ID Numbers: 25198
Study First Received: November 4, 2005
Last Updated: February 17, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck KGaA:
Healthy female partners of infertile couples justifying Assisted Reproductive Technology (ART) treatment.

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

ClinicalTrials.gov processed this record on April 15, 2014