InfertilityPhase 3PURSUENCT01144416

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

A Phase 3 study testing SCH 900962 / Corifollitropin alfa / Org 36286 and RecFSH / follitropin beta in people with Infertility, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 42 years, women only
Conditions the study is for: Infertility
What is being tested?: SCH 900962 / Corifollitropin alfa / Org 36286 and RecFSH / follitropin beta
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,424 participants
Where: No sites listed yet
Study dates: Jun 2010to Apr 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 42 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 18Show fewer

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.

About this study

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)

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
Being tested: SCH 900962 / Corifollitropin alfa / Org 36286, RecFSH / follitropin beta, Placebo for SCH 900962, Placebo for recFSH
Keywords: Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Medical subject headings: Infertility, Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCH 900962 / Corifollitropin alfa / Org 36286Biological
Also called MK-8962
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 betaBiological
Also called Follistim® AQ Cartridge
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.
Placebo for SCH 900962Drug
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 recFSHDrug
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.

Study groups in NCT01144416
Study group	Role	What they receive
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 Receives: 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 Receives: Biological: RecFSH / follitropin beta; Drug: Placebo for SCH 900962

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).
Measured: Maximally 21 days after the start of study treatment.
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.
Measured: Approximately nine months after embryo transfer
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.
Measured: Up to approximately 1 month after oocyte pick-up
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.
Measured: Up to time of embryo transfer (maximum of 24 days after start of study drug)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Apr 2012

First posted15 Jun 2010 (estimated)
Study startJun 2010
Primary completionJul 2011
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for InfertilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01144416
Sponsor's protocol ID: P06029
Acronym: PURSUE
Status last verified: Feb 2022
First submitted: 11 Jun 2010
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 26003273
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.
PubMed 27619773
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.
PubMed 26991902
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.
PubMed 26520396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01144416
Acronym / sponsor ID: PURSUE / P06029
Conditions: Infertility
Keywords: Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,424 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jul 2011 (actual)
Study completion: Apr 2012 (actual)
First posted: 15 Jun 2010 (estimated)
Results: Posted 27 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Single injection of 150 µg SCH 900962 (MK-8962)	Experimental	Biological: SCH 900962 / Corifollitropin alfa / Org 36286, Drug: Placebo for recFSHParticipants 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
Daily 300 IU recFSH	Active comparator	Biological: RecFSH / follitropin beta, Drug: Placebo for SCH 900962Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7

Who may qualify

Ages: 35 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCH 900962 / Corifollitropin alfa / Org 36286Also: MK-8962SCH 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.	Biological	Single injection of 150 µg SCH 900962 (MK-8962)
RecFSH / follitropin betaAlso: Follistim® AQ CartridgeRecFSH 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.	Biological	Daily 300 IU recFSH
Placebo for SCH 900962Supplied 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.	Drug	Daily 300 IU recFSH
Placebo for recFSHSupplied 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.	Drug	Single injection of 150 µg SCH 900962 (MK-8962)

Primary outcome

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

4 secondary outcomes

Number of Oocytes Retrieved Per Attempt
Time frame: Maximally 21 days after the start of study treatment.
Live Birth Rate
Time frame: Approximately nine months after embryo transfer
Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: Up to approximately 1 month after oocyte pick-up
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)

Results and safety

Results posted to the registry on 27 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Injection of 150 µg SCH 900962/MK-8962	694	632
Daily 300 IU recFSH	696	647

Primary outcome: 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.. Number. Unit: percentage of participants

Measure	Single Injection of 150 µg SCH 900962/MK-8962 n = 694	Daily 300 IU recFSH n = 696
Value	23.9	26.9

Single Injection of 150 µg SCH 900962/MK-8962 vs Daily 300 IU recFSH: Difference in percentage vital pregnancy: -3.0 (95% CI -7.4 to 1.4), generalized linear model

Population analysed: Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Injection of 150 µg SCH 900962/MK-8962	4 of 692 (0.6%)	267 of 692 (38.6%)	Not reported
Daily 300 IU recFSH	19 of 698 (2.7%)	262 of 698 (37.5%)	Not reported
Single Injection of 150 µg SCH 900962/MK-8962-Follow-up	110 of 154 (71.4%)	94 of 154 (61%)	Not reported
Daily 300 IU recFSH -Follow-up	112 of 167 (67.1%)	105 of 167 (62.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26003273Boostanfar 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.
Derived from this study: PubMed 27619773Lawrenz 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.
Derived from this study: PubMed 26991902Zandvliet 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.
Derived from this study: PubMed 26520396Oehninger 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCH 900962 / Corifollitropin alfa / Org 36286 and RecFSH / follitropin beta in people with Infertility, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144416, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.