Trial · NCT00696878
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
NCT00696878, Phase 3, Completed, Organon and Co; results first posted 2015-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714). Trials, record NCT00696878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00696878
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
- NCT number
- NCT00696878
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 682 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- In Vitro Fertilization
- Interventions
- Corifollitropin alfa, FSH, GnRH antagonist, (rec)hCG, Progesterone
- First posted
- 2008-06-13
- Last updated
- 2024-06-18
- Other registries' IDs
- eudract:2004-004966-34
- Results first posted
- 2015-04-23
Source ClinicalTrials.gov
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinically Relevant Immunogenicity | 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 would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | 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 | 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. |
| Primary | Number of Participants With AEs | 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. |
| Primary | Number of Participants With Serious AEs (SAEs) | 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. |
| Primary | Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | 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. 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 haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena. |
| Secondary | Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | 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. |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 registered outcomesOutcomes69
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinically Relevant Immunogenicity | Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle | Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing | percentage of participants | NUMBER |
| PRIMARY | 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 | 30 minutes post dose in each treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | 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 | 30 minutes post dose in each treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | 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 | 30 minutes post dose in each treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | 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 | 30 minutes post dose in each treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | 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 | 30 minutes post dose in each treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | Number of Participants With AEs | Up to approximately 26 months after first dose of corifollitropin alfa | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | Number of Participants With Serious AEs (SAEs) | Up to approximately 26 months after first dose of corifollitropin alfa | Participants who received corifollitropin alfa | participants | NUMBER |
| PRIMARY | Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS) | Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle | Participants who received corifollitropin alfa | participants | NUMBER |
| SECONDARY | Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG | Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle | Participants who received corifollitropin alfa and (rec)hCG | International Unit (IU) | MEDIAN |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 outcomesResults by group285
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinically Relevant Immunogenicity | Corifollitropin Alfa 150 µg | Cycle 1 (n=681) | 0.0 | percentage of participants | |
| Percentage of Participants With Clinically Relevant Immunogenicity | Corifollitropin Alfa 150 µg | Cycle 2 (n=372) | 0.0 | percentage of participants | |
| Percentage of Participants With Clinically Relevant Immunogenicity | Corifollitropin Alfa 150 µg | Cycle 3 (n=192) | 0.0 | percentage of participants | |
| 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 | Corifollitropin Alfa 150 µg | None | 679 | participants | |
| 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 | Corifollitropin Alfa 150 µg | Mild | 3 | participants | |
| 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 | Corifollitropin Alfa 150 µg | Moderate | 0 | participants | |
| 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 | Corifollitropin Alfa 150 µg | Severe | 0 | participants | |
| 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 | Corifollitropin Alfa 150 µg | None | 678 | participants | |
| 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 | Corifollitropin Alfa 150 µg | Mild | 4 | participants | |
| 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 | Corifollitropin Alfa 150 µg | Moderate | 0 | participants |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Corifollitropin Alfa 150 µg | 682 | |
| Overall Study | COMPLETED | Corifollitropin Alfa 150 µg | 178 | |
| Overall Study | NOT COMPLETED | Corifollitropin Alfa 150 µg | 504 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pain | Injury, poisoning and procedural complications | Corifollitropin Alfa 150 µg | 121 | 682 | 163 |
| other | Headache | Nervous system disorders | Corifollitropin Alfa 150 µg | 62 | 682 | 91 |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Corifollitropin Alfa 150 µg | 48 | 682 | 51 |
| other | Pelvic discomfort | Reproductive system and breast disorders | Corifollitropin Alfa 150 µg | 35 | 682 | 39 |
| other | Pelvic pain | Reproductive system and breast disorders | Corifollitropin Alfa 150 µg | 51 | 682 | 60 |
| serious | Autosomal chromosome anomaly | Congenital, familial and genetic disorders | Corifollitropin Alfa 150 µg | 1 | 682 | 2 |
| serious | Congenital arterial malformation | Congenital, familial and genetic disorders | Corifollitropin Alfa 150 µg | 1 | 682 | 1 |
| serious | Congenital uterine anomaly | Congenital, familial and genetic disorders | Corifollitropin Alfa 150 µg | 1 | 682 | 1 |
| serious | Cytogenetic abnormality | Congenital, familial and genetic disorders | Corifollitropin Alfa 150 µg | 1 | 682 | 1 |
| serious | Ectopia cordis | Congenital, familial and genetic disorders | Corifollitropin Alfa 150 µg | 1 | 682 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Corifollitropin Alfa 150 µg | ||
| Total, other adverse events | Corifollitropin Alfa 150 µg | 239 | 682 |
| Total, serious adverse events | Corifollitropin Alfa 150 µg | 51 | 682 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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