Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)

Infertility Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144416
• Other study ID #: P06029
• Status: Completed
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1424
• Est. completion date: April 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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).	Maximally 21 days after the start of study treatment.
Secondary	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.	Approximately nine months after embryo transfer
Secondary	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.	Up to approximately 1 month after oocyte pick-up
Secondary	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.	Up to time of embryo transfer (maximum of 24 days after start of study drug)