Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
| Group | Value (oocytes) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 8.6 | 6.54 |
| Gonal-f® Followed by Luveris | 8.7 | 5.77 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Study was terminated as per sponsor's decision
Results were posted for this trial.
United Arab Emirates
1 trial · 1 stopped early · 1 with posted results
A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
NCT01497197May 2012 to Jan 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).
Experimental
Gonal-f®+Luveris®
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Experimental
Gonal-f® Followed by Luveris®
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level is met. The dose will be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Outcomes the sponsor listed as primary.
Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
Time frame · 34-38 hours post r-hCG administration
Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Time frame · Screening
Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.
Total Number of Stimulation Treatment Days
Time frame · 6 days post stimulation (Number of stimulation days+6 days)
The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.
Implantation Rate
Time frame · 35-42 days post r-hCG administration
The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.
Number of Fetal Sacs With Activity
Time frame · 35-42 days post r-hCG administration
Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy.
Number of Fetal Sacs With Detectable Heart Beats
Time frame · 35-42 days post r-hCG administration
Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy
Total Pregnancy Rate and Clinical Pregnancy Rate
Time frame · 35-42 days post r-hCG administration
The subject was considered to have a positive pregnancy result if beta-hCG \>10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42.
Cycle Cancellation Rate Prior to r-hCG
Time frame · Up to 85 days
If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.
Number of Subjects With Biochemical Pregnancies
Time frame · 35 to 42 days post r-hCG administration
Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.
Number of Subjects With Multiple Pregnancies
Time frame · 35 to 42 days post r-hCG administration
Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42.
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
Time frame · Baseline up to 15-20 days post r-hCG administration
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (oocytes) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 8.6 | 6.54 |
| Gonal-f® Followed by Luveris | 8.7 | 5.77 |
| Group | Value |
|---|---|
| Gonal-f®+Luveris | not posted |
| Gonal-f® Followed by Luveris | not posted |
| Group | Value (days) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 11.1 | 2.42 |
| Gonal-f® Followed by Luveris | 11.3 | 2.24 |
| Group | Value (fetal sacs/embryo transferred) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 0.5 | 0.51 |
| Gonal-f® Followed by Luveris | 0.4 | 0.51 |
| Group | Value (Fetal sacs) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 0.8 | 0.42 |
| Gonal-f® Followed by Luveris | 1.1 | 0.54 |
| Group | Value (Fetal sacs) | Spread |
|---|---|---|
| Gonal-f®+Luveris | 0.6 | 0.50 |
| Gonal-f® Followed by Luveris | 1.0 | 0.45 |
| Group | Value (percentage of subjects) |
|---|---|
| Gonal-f®+Luveris | 20 |
| Gonal-f® Followed by Luveris | 27 |
| Group | Value (percentage of subjects) |
|---|---|
| Gonal-f®+Luveris | 0 |
| Gonal-f® Followed by Luveris | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Gonal-f®+LuverisGONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. | – | 4 / 89 | 24 / 89 |
| Gonal-f® Followed by LuverisGONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. | – | 5 / 85 | 27 / 85 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated