Back to resultsEfficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (PURSUE)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SCH 900962 / Corifollitropin alfa / Org 36286
RecFSH / follitropin beta
Placebo for SCH 900962
Placebo for recFSH
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable).
- Female and >=35 to <=42 years of age with indication for COS and IVF/ICSI.
- Body weight ≥50.0 kg, body mass index (BMI) >=18.0 to <=32.0 kg/m2.
- Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
- Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
- Results of clinical laboratory tests, cervical smear, physical examination within normal limits or clinically acceptable to the investigator.
- Adhere to trial schedule.
Exclusion Criteria:
- A recent history of/or any current endocrine abnormality.
- A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
- A history of/or current polycystic ovary syndrome.
- More than 20 basal antral follicles <11 mm (both ovaries combined) in the early follicular phase.
- Less than 2 ovaries or any other ovarian abnormality.
- Unilateral or bilateral hydrosalpinx.
- Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
- More than three unsuccessful COS cycles for IVF/ICSI since the last established ongoing pregnancy (if applicable).
- A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment.
- A history of recurrent miscarriage.
- FSH >15.0 IU/L or luteinizing hormone (LH) >12.0 IU/L during the early follicular phase.
- Positive for human immunodeficiency virus (HIV) or Hepatitis B.
- Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
- A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
- Smoking or recently stopped smoking (ie, within the last 3 months prior to signing informed consent).
- A recent history or presence of alcohol or drug abuse.
- The participant or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indication or for the health of the offspring.
- Prior or concomitant medications disallowed by protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single injection of 150 µg SCH 900962 (MK-8962)
Daily 300 IU recFSH
Arm Description
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
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
Outcomes
Primary Outcome Measures
Percentage of Participants With a Vital Pregnancy
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
Secondary Outcome Measures
Number of Oocytes Retrieved Per Attempt
The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).
Live Birth Rate
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)
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
The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01144416
Brief Title
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Acronym
PURSUE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single injection of 150 µg SCH 900962 (MK-8962)
Arm Type
Experimental
Arm Description
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
Arm Title
Daily 300 IU recFSH
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
SCH 900962 / Corifollitropin alfa / Org 36286
Other Intervention Name(s)
MK-8962
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
RecFSH / follitropin beta
Other Intervention Name(s)
Follistim® AQ Cartridge
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo for SCH 900962
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo for recFSH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Vital Pregnancy
Description
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
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.
Secondary Outcome Measure Information:
Title
Number of Oocytes Retrieved Per Attempt
Description
The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).
Time Frame
Maximally 21 days after the start of study treatment.
Title
Live Birth Rate
Description
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.
Time Frame
Approximately nine months after embryo transfer
Title
Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)
Description
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.
Time Frame
Up to approximately 1 month after oocyte pick-up
Title
Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event
Description
The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.
Time Frame
Up to time of embryo transfer (maximum of 24 days after start of study drug)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable).
Female and >=35 to <=42 years of age with indication for COS and IVF/ICSI.
Body weight ≥50.0 kg, body mass index (BMI) >=18.0 to <=32.0 kg/m2.
Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
Results of clinical laboratory tests, cervical smear, physical examination within normal limits or clinically acceptable to the investigator.
Adhere to trial schedule.
Exclusion Criteria:
A recent history of/or any current endocrine abnormality.
A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
A history of/or current polycystic ovary syndrome.
More than 20 basal antral follicles <11 mm (both ovaries combined) in the early follicular phase.
Less than 2 ovaries or any other ovarian abnormality.
Unilateral or bilateral hydrosalpinx.
Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
More than three unsuccessful COS cycles for IVF/ICSI since the last established ongoing pregnancy (if applicable).
A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment.
A history of recurrent miscarriage.
FSH >15.0 IU/L or luteinizing hormone (LH) >12.0 IU/L during the early follicular phase.
Positive for human immunodeficiency virus (HIV) or Hepatitis B.
Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
Smoking or recently stopped smoking (ie, within the last 3 months prior to signing informed consent).
A recent history or presence of alcohol or drug abuse.
The participant or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indication or for the health of the offspring.
Prior or concomitant medications disallowed by protocol.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26003273
Citation
Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.
Results Reference
result
PubMed Identifier
27619773
Citation
Lawrenz B, Beligotti F, Engelmann N, Gates D, Fatemi HM. Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles. Hum Reprod. 2016 Nov;31(11):2554-2560. doi: 10.1093/humrep/dew213. Epub 2016 Sep 12.
Results Reference
derived
PubMed Identifier
26991902
Citation
Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
Results Reference
derived
PubMed Identifier
26520396
Citation
Oehninger S, Nelson SM, Verweij P, Stegmann BJ. Predictive factors for ovarian response in a corifollitropin alfa/GnRH antagonist protocol for controlled ovarian stimulation in IVF/ICSI cycles. Reprod Biol Endocrinol. 2015 Oct 31;13:117. doi: 10.1186/s12958-015-0113-1.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
We'll reach out to this number within 24 hrs