NCT00696878 (Trust) is a Phase 3 clinical trial of Corifollitropin alfa in In Vitro Fertilization, sponsored by Organon and Co.

Who is sponsoring NCT00696878?

NCT00696878 is sponsored by Organon and Co.

What drugs are being tested in NCT00696878?

Interventions in NCT00696878: Corifollitropin alfa, FSH, GnRH antagonist, (rec)hCG, Progesterone.

What condition does NCT00696878 study?

NCT00696878 studies In Vitro Fertilization.

Is NCT00696878 still recruiting?

NCT00696878 is currently completed. Last updated 18 June 2024.

Are results published for NCT00696878?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-18 · How we verify

NCT00696878: Trust

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

Completed Phase 3 Results posted Last updated 18 June 2024

What this trial tests

Phase 3 trial testing Corifollitropin alfa in In Vitro Fertilization in 682 participants. Completed in 15 May 2009.

Timeline

26 September 2006

Primary endpoint
17 February 2009

15 May 2009

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	682
Start date	26 September 2006
Primary completion	17 February 2009
Estimated completion	15 May 2009

Drugs / interventions tested

Corifollitropin alfa (CORIFOLLITROPIN ALFA) — full drug profile →
FSH
GnRH antagonist — full drug profile →
(rec)hCG
Progesterone (Progesterone plus HCG) — full drug profile →

Conditions studied

In Vitro Fertilization — all drugs for In Vitro Fertilization →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 39, female only, with In Vitro Fertilization. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Clinically Relevant Immunogenicity Primary · Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle

Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that wou

Cycle 1 (n=681)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0

Cycle 2 (n=372)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0

Cycle 3 (n=192)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0

Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles Primary · 30 minutes post dose in each treatment cycle

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.

None

Group	Value	95% CI
Corifollitropin Alfa 150 µg	679

Mild

Group	Value	95% CI
Corifollitropin Alfa 150 µg	3

Moderate

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Severe

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles Primary · 30 minutes post dose in each treatment cycle

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.

None

Group	Value	95% CI
Corifollitropin Alfa 150 µg	678

Mild

Group	Value	95% CI
Corifollitropin Alfa 150 µg	4

Moderate

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Severe

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles Primary · 30 minutes post dose in each treatment cycle

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.

None

Group	Value	95% CI
Corifollitropin Alfa 150 µg	654

Mild

Group	Value	95% CI
Corifollitropin Alfa 150 µg	28

Moderate

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Severe

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles Primary · 30 minutes post dose in each treatment cycle

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.

None

Group	Value	95% CI
Corifollitropin Alfa 150 µg	680

Mild

Group	Value	95% CI
Corifollitropin Alfa 150 µg	2

Moderate

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Severe

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles Primary · 30 minutes post dose in each treatment cycle

At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.

None

Group	Value	95% CI
Corifollitropin Alfa 150 µg	647

Mild

Group	Value	95% CI
Corifollitropin Alfa 150 µg	35

Moderate

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Severe

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Number of Participants With AEs Primary · Up to approximately 26 months after first dose of corifollitropin alfa

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Group	Value	95% CI
Corifollitropin Alfa 150 µg	409

Number of Participants With Serious AEs (SAEs) Primary · Up to approximately 26 months after first dose of corifollitropin alfa

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.

Group	Value	95% CI
Corifollitropin Alfa 150 µg	51

Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) Primary · Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounc

Cycle 1 (n=682)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	12

Cycle 2 (n=375)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	4

Cycle 3 (n=198)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0

Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG Secondary · Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle

Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.

Cycle 1 (n=658)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	400.0	0 – 2100

Cycle 2 (n=364)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	450.0	0 – 1950

Cycle 3 (n=190)

Group	Value	95% CI
Corifollitropin Alfa 150 µg	450.0	0 – 2250

Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1 Secondary · Stimulation Day 1 in Treatment Cycle 1

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

follicles ≥11 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.1

follicles ≥15 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.1

follicles ≥17 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.1

Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2 Secondary · Stimulation Day 1 in Treatment Cycle 2

For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

follicles ≥11 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.3

follicles ≥15 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.0

follicles ≥17 mm

Group	Value	95% CI
Corifollitropin Alfa 150 µg	0.0	± 0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 26 months after first dose of corifollitropin alfa. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Corifollitropin Alfa 150 µg

Serious: 51/682 (7%)

Deaths: —

Serious adverse events (47 terms)

Reaction	System	Corifollitropin Alfa 150 µg
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	—
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	—
Abortion missed	Pregnancy, puerperium and perinatal conditions	—
Premature baby	Pregnancy, puerperium and perinatal conditions	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	—
Imminent abortion	Pregnancy, puerperium and perinatal conditions	—
Premature labour	Pregnancy, puerperium and perinatal conditions	—
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	—
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	—
Endometriosis	Reproductive system and breast disorders	—
Autosomal chromosome anomaly	Congenital, familial and genetic disorders	—
Congenital arterial malformation	Congenital, familial and genetic disorders	—
Congenital uterine anomaly	Congenital, familial and genetic disorders	—
Cytogenetic abnormality	Congenital, familial and genetic disorders	—
Ectopia cordis	Congenital, familial and genetic disorders	—
Encephalocele	Congenital, familial and genetic disorders	—
Trisomy 15	Congenital, familial and genetic disorders	—
Conjunctivitis	Eye disorders	—
Abdominal pain	Gastrointestinal disorders	—
Peritoneal haemorrhage	Gastrointestinal disorders	—
Cholelithiasis	Hepatobiliary disorders	—
Appendicitis	Infections and infestations	—
Post procedural infection	Infections and infestations	—

Other adverse events (5 terms — click to expand)

Reaction	System	Corifollitropin Alfa 150 µg
Procedural pain	Injury, poisoning and procedural complications	—
Headache	Nervous system disorders	—
Pelvic pain	Reproductive system and breast disorders	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—
Pelvic discomfort	Reproductive system and breast disorders	—

Most-reported serious reactions: Ovarian hyperstimulation syndrome, Ectopic pregnancy, Abortion missed, Premature baby, Uterine leiomyoma, Abortion spontaneous, Hyperemesis gravidarum, Imminent abortion.

Data from ClinicalTrials.gov NCT00696878 adverse events section.

Sponsor's own description

The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol.
Griesinger G, Verweij PJ, Gates D, Devroey P, et al · · 2016 · cited 63× · PMID 26950065 · DOI 10.1371/journal.pone.0149615
Repeated ovarian stimulation with corifollitropin alfa in patients in a GnRH antagonist protocol: no concern for immunogenicity.
Norman RJ, Zegers-Hochschild F, Salle BS, Elbers J, et al · · 2011 · cited 25× · PMID 21622693 · DOI 10.1093/humrep/der163
Intercycle variability of the ovarian response in patients undergoing repeated stimulation with corifollitropin alfa in a gonadotropin-releasing hormone antagonist protocol.
Rombauts L, Lambalk CB, Schultze-Mosgau A, van Kuijk J, et al · · 2015 · cited 23× · PMID 26187300 · DOI 10.1016/j.fertnstert.2015.06.027
Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation.
Zandvliet AS, Prohn M, de Greef R, van Aarle F, et al · · 2016 · cited 4× · PMID 26991902 · DOI 10.1111/bcp.12939

Verify or expand the search:

Other trials of Corifollitropin alfa

Trials testing the same drug.

NCT04695483 — Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Rando · Phase 4 · completed
NCT04482751 — The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa · unknown
NCT03019575 — Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolesce · Phase 3 · completed
NCT01709331 — A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (h · Phase 3 · completed
NCT01146418 — Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) · Phase 3 · completed

Other recruiting trials for In Vitro Fertilization

Currently open trials in the same condition.

NCT07500337 — Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes · NA · recruiting
NCT06766604 — Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles · NA · recruiting
NCT06261671 — Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates. · NA · recruiting
NCT06521957 — Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program · NA · recruiting
NCT06670586 — Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus · NA · active not recruiting

Other Organon and Co trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00696878 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 18 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00696878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00696878: Trust

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (47 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Corifollitropin alfa

Other recruiting trials for In Vitro Fertilization

Other Organon and Co trials

Verify against primary sources