CONSORT Randomized Controlled Trial in Assisted Reproductive Technology
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|ClinicalTrials.gov Identifier: NCT00829244|
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : September 7, 2012
Last Update Posted : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: GONAL f® prefilled pen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV Prospective, Multicenter, 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)|
|Study Start Date :||August 2008|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
Experimental: CONSORT Dosing
GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator
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 1 cycle only
Active Comparator: Standard Dosing
GONAL-f® at a standard dose of 150 IU per day
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 center's standard practice.
- Number of Oocytes Retrieved Per Participant [ Time Frame: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU) ]Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
- Total GONAL-f® Dose [ Time Frame: Start of treatment until end of stimulation cycle (approximately 28 days) ]
- Mean GONAL-f® Daily Dose [ Time Frame: Start of treatment until end of stimulation cycle (approximately 28 days) ]
- Total Number of GONAL-f® Stimulation Treatment Days [ Time Frame: Start of treatment until end of stimulation cycle (approximately 28 days) ]
- Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment [ Time Frame: Start of treatment until Day 15-20 post-hCG ]Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.
- Percentage of Participants With Biochemical Pregnancies [ Time Frame: Start of treatment until Day 15-20 Post-hCG ]Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.
- Number of Participants With Fetal Sacs and Fetal Hearts [ Time Frame: Day 35-42 Post-hCG ]Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.
- Implantation Rate [ Time Frame: Day 35-42 Post-hCG ]Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
- Number of Participants With Multiple Pregnancies [ Time Frame: Day 35-42 Post-hCG ]Multiple pregnancy was defined as 2 or more fetal hearts with activity.
- Serum Progesterone (P4) Levels [ Time Frame: End of stimulation cycle (approximately 28 days) ]
- Percentage of Participants With Clinical Pregnancy [ Time Frame: Day 35-42 Post-hCG ]Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.
- Number of Participants With OHSS [ Time Frame: Start of treatment until Day 15-20 Post-hCG ]OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
- Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome [ Time Frame: up to 9 month (following the end of treatment) ]Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829244
|Study Director:||Pablo Arriagada, MD||Merck Serono S.A., Geneva|