Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (PURSUE)
|Infertility||Biological: SCH 900962 / Corifollitropin alfa / Org 36286 Biological: RecFSH / follitropin beta Drug: Placebo for SCH 900962 Drug: Placebo for recFSH||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-blind, Active-controlled, Non-inferiority Trial to Investigate the Efficacy and Safety of a Single Injection of SCH 900962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference in Women Aged 35 to 42 Years (Phase 3; Protocol No. P06029)|
- Percentage of Participants With a Vital Pregnancy [ Time Frame: Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days. ]Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
- Number of Oocytes Retrieved Per Attempt [ Time Frame: Maximally 21 days after the start of study treatment. ]The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).
- Live Birth Rate [ Time Frame: Approximately nine months after embryo transfer ]The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.
- Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: Up to approximately 1 month after oocyte pick-up ]
Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea.
Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.
- Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event [ Time Frame: Up to time of embryo transfer (maximum of 24 days after start of study drug) ]The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.
|Study Start Date:||June 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Single injection of 150 µg SCH 900962 (MK-8962)
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
Biological: SCH 900962 / Corifollitropin alfa / Org 36286
SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning.
Other Name: MK-8962Drug: Placebo for recFSH
Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days.
Active Comparator: Daily 300 IU recFSH
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
Biological: RecFSH / follitropin beta
RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days.
Other Name: Follistim® AQ CartridgeDrug: Placebo for SCH 900962
Supplied as a pre-filled syringe containing an identical solution when
compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall.
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