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CONSORT Randomised Controlled Trial in Assisted Reproductive Technology
This study is currently recruiting participants.
Verified by EMD Serono, March 2009
First Received: January 22, 2009   Last Updated: March 21, 2009   History of Changes
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00829244
  Purpose

The overall objective of this trial is to compare the ovarian response in ART subjects administered GONAL f® according to the CONSORT calculator versus given a standard GONAL f® dose of 150 IU per day.


Condition Intervention Phase
Infertility
Drug: GONAL f® prefilled pen
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase IV Prospective, Multicentre, Randomized, Open-Label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The primary efficacy endpoint will be measured by the total number of oocytes retrieved per subject following GONAL-f® stimulation and human chorionic gonadotrophin (r-hCG - Ovidrel®/Ovitrelle®) injection in both treatment arms. [ Time Frame: Oocytes will be recovered 34-38 hours after r-hCG (r-hCG - Ovidrel®/Ovitrelle®) administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total dose of GONAL f® used (in IU); mean daily dose of GONAL f® (in IU); total number of GONAL f® stimulation treatment days; cycle cancellation for excessive or inadequate response to GONAL f®; number of biochemical pregnancies (by serum hCG levels); [ Time Frame: Screening: AMH, P4 and PGx. End of cycle: total & mean FSH used; total stimulation days; cycle cancellation; implantation; total & clinical & multiple pregnancy; Clinical pregnancy by US. hCG Day: P4. Post hCG Day 15-20: beta-hCG ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: GONAL f® prefilled pen
GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for one cycle only
2: Active Comparator Drug: GONAL f® prefilled pen
GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the centre's standard practice.

  Eligibility

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

Inclusion Criteria:

  1. Be a female subject justifying an IVF/ET treatment,
  2. Have a male partner with semen analysis within the past 6 months prior to randomisation 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,
  3. Be between her 18th and 35th birthday (35 not included) at the time of the randomisation visit,
  4. A body mass index (BMI) lower than 30 kg/m2 where the BMI is calculated according to the formula.
  5. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length,
  6. Have early follicular phase (day 2-4) serum level of basal FSH lower and equal to 12 IU/L measured in the centre's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start),
  7. Presence of both ovaries,
  8. Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy,
  9. Have a negative cervical PAP test within the last 6 months prior to randomisation,
  10. Have at least one wash-out cycle (defined as greater and equal to 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,
  11. Be willing and able to comply with the protocol for the duration of the trial,
  12. Have given written informed consent, prior to any trial-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:

  1. Had greater or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower or equal to 5 mature follicles and/or lower or equal to 3 oocytes collected) or had greater or equal to 2 previous ART cycles with a hyper response (defined as greater or equal to 25 oocytes retrieved),
  2. 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 Merck Serono's Medical responsible,
  3. Had previous severe OHSS,
  4. Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS,
  5. Presence of endometriosis requiring treatment,
  6. Uterine myoma requiring treatment,
  7. Any contraindication to being pregnant and/or carrying a pregnancy to term,
  8. Extra-uterine pregnancy within the last 3 months prior to screening,
  9. History of 3 or more miscarriages (early or late miscarriages) due to any cause,
  10. Have at least one wash-out cycle (defined as greater and equal to 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,
  11. Ovarian enlargement or cyst of unknown aetiology,
  12. Ovarian, uterine or mammary cancer,
  13. A clinically significant systemic disease,
  14. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,
  15. Abnormal gynaecological bleeding of undetermined origin,
  16. Known allergy or hypersensitivity to human gonadotrophin preparations,
  17. Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit,
  18. Entered previously into this trial or simultaneous participation in another clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829244

Locations
Switzerland
Research Site Recruiting
Geneva, Switzerland
Contact: Local Medical Information     +41-41-747-0812        
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Mark O'Brien, MD Merck Serono S.A. - Geneva
  More Information

No publications provided

Responsible Party: Merck Serono S.A. - Geneva, an Affiliate of Merck KGaA Darmstadt, Germany ( Shelly Bustion )
Study ID Numbers: 28613
Study First Received: January 22, 2009
Last Updated: March 21, 2009
ClinicalTrials.gov Identifier: NCT00829244     History of Changes
Health Authority: Australia: Human Research Ethics Committee;   Chile: Comisión Nacional de Investigación Científica y Tecnológica;   Chile: Instituto de Salud Publica de Chile;   Denmark: Danish Dataprotection Agency;   Denmark: Danish Medicines Agency;   Denmark: The Regional Committee on Biomedical Research Ethics;   France: Afssaps - French Health Products Safety Agency;   France: Institutional Ethical Committee;   France: National Consultative Ethics Committee for Health and Life Sciences;   Germany: Ethics Commission;   Germany: Federal Institute for Drugs and Medical Devices;   Italy: Ethics Committee;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Netherlands: Medical Ethics Review Committee (METC);   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Spain: Comité Ético de Investigación Clínica;   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency;   Sweden: Regional Ethical Review Board;   Switzerland: Ethikkommission;   Switzerland: Swissmedic;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: Research Ethics Committee

Keywords provided by EMD Serono:
Infertility
Assisted reproductive technology

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Genital Diseases, Male

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

ClinicalTrials.gov processed this record on September 10, 2009