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

NCT01144416 | Completed Phase 3 Results DMC

• 1 other identifier: P06029
• Study Type: interventional
• Target: 1,424
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infertility

Keywords

Reproductive Techniques, Assisted; Follicle Stimulating Hormone, Human; Fertilization In Vitro

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Oocytes Retrieved Per Attempt

  Maximally 21 days after the start of study treatment.

• Live Birth Rate

  Approximately nine months after embryo transfer

• Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)

  Up to approximately 1 month after oocyte pick-up

• Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event

  Up to time of embryo transfer (maximum of 24 days after start of study drug)

Study Arms (2)

Single injection of 150 µg SCH 900962 (MK-8962)

EXPERIMENTAL

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; Drug: Placebo for recFSH

Daily 300 IU recFSH

ACTIVE COMPARATOR

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; Drug: Placebo for SCH 900962

Interventions

SCH 900962 / Corifollitropin alfa / Org 36286 BIOLOGICAL

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.

Also known as: MK-8962

Single injection of 150 µg SCH 900962 (MK-8962)

RecFSH / follitropin beta BIOLOGICAL

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.

Also known as: Follistim® AQ Cartridge

Daily 300 IU recFSH

Placebo for SCH 900962 DRUG

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.

Daily 300 IU recFSH

Placebo for recFSH DRUG

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.

Single injection of 150 µg SCH 900962 (MK-8962)

Eligibility Criteria

• Age: 35 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (4)

• 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.

  PMID: 26003273 RESULT

• 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.

  PMID: 27619773 DERIVED

• 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.

  PMID: 26991902 DERIVED

• 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.

  PMID: 26520396 DERIVED

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: April 1, 2012
• Last Updated: February 3, 2022
• Results First Posted: December 27, 2012

Record last verified: 2022-02