Trial · NCT00702845
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
NCT00702845, Phase 3, Completed, Organon and Co; results first posted 2015-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001). Trials, record NCT00702845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00702845
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
- NCT number
- NCT00702845
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Infertility
- Interventions
corifollitropin alfa (Org 36286), recFSH (follitropin beta), gonadatropin releasing hormone (GnRH) antagonist (ganirelix), human chorion gonadatropin (hCG), progesterone, placebo-recFSH (follitropin alfa), placebo-corifollitropin alfa, open-label recFSH
- First posted
- 2008-06-20
- Last updated
- 2024-06-18
- Other registries' IDs
- eudract:2006-003811-36
- Results first posted
- 2015-04-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Cumulus-oocyte-complexes Retrieved, Per Attempt | One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days) | The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero. |
| Secondary | Total Dose of recFSH Administered | One COS cycle (up to a maximum total duration of 19 stimulation days) | Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles \>=17mm). |
| Secondary | Total Dose of recFSH Administered From Day 8 Onwards | Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days) | Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles \>=17mm). |
| Secondary | Number of Days Treated With recFSH | One COS cycle (up to a maximum total duration of 19 stimulation days) | Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles \>=17mm). |
| Secondary | Total Duration of Stimulation (Days) | One COS cycle (up to a maximum total duration of 19 stimulation days) | Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration. |
| Secondary | Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. |
| Secondary | Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. |
| Secondary | Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. |
| Secondary | Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. |
| Secondary | Serum Inhibin-B Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Cumulus-oocyte-complexes Retrieved, Per Attempt | One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days) | Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH. | Number of cumulus-oocyte-complexes | MEAN |
| SECONDARY | Total Dose of recFSH Administered | One COS cycle (up to a maximum total duration of 19 stimulation days) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | International Unit (IU) | MEDIAN |
| SECONDARY | Total Dose of recFSH Administered From Day 8 Onwards | Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | International Unit (IU) | MEDIAN |
| SECONDARY | Number of Days Treated With recFSH | One COS cycle (up to a maximum total duration of 19 stimulation days) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | Days | MEDIAN |
| SECONDARY | Total Duration of Stimulation (Days) | One COS cycle (up to a maximum total duration of 19 stimulation days) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | Days | MEDIAN |
| SECONDARY | Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | IU/L | MEDIAN |
| SECONDARY | Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | IU/L | MEDIAN |
| SECONDARY | Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | pmol/L | MEDIAN |
| SECONDARY | Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | nmol/L | MEDIAN |
| SECONDARY | Serum Inhibin-B Levels (Restricted to Participants With hCG Injection) | Predose up to 2 weeks after ET (up to maximum of 6 weeks) | Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG. | pg/mL | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Cumulus-oocyte-complexes Retrieved, Per Attempt | 100 μg Corifollitropin Alfa | 13.3 | Standard Deviation 7.3 | Number of cumulus-oocyte-complexes | |
| Number of Cumulus-oocyte-complexes Retrieved, Per Attempt | 150 IU recFSH | 10.6 | Standard Deviation 5.9 | Number of cumulus-oocyte-complexes | |
| Total Dose of recFSH Administered | 100 μg Corifollitropin Alfa | 300.0 | Full Range 0 to 1550 | International Unit (IU) | |
| Total Dose of recFSH Administered | 150 IU recFSH | 1350.0 | Full Range 825 to 2650 | International Unit (IU) | |
| Total Dose of recFSH Administered From Day 8 Onwards | 100 μg Corifollitropin Alfa | 300.0 | Full Range 0 to 1550 | International Unit (IU) | |
| Total Dose of recFSH Administered From Day 8 Onwards | 150 IU recFSH | 275.0 | Full Range 0 to 1600 | International Unit (IU) | |
| Number of Days Treated With recFSH | 100 μg Corifollitropin Alfa | 2.0 | Full Range 0 to 7 | Days | |
| Number of Days Treated With recFSH | 150 IU recFSH | 9.0 | Full Range 6 to 15 | Days | |
| Total Duration of Stimulation (Days) | 100 μg Corifollitropin Alfa | 9.0 | Full Range 6 to 15 | Days | |
| Total Duration of Stimulation (Days) | 150 IU recFSH | 9.0 | Full Range 6 to 15 | Days |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 100 μg Corifollitropin Alfa | 268 | |
| Overall Study | STARTED | 150 IU recFSH | 129 | |
| Overall Study | Randomized | 100 μg Corifollitropin Alfa | 268 | |
| Overall Study | Randomized | 150 IU recFSH | 128 | |
| Overall Study | COMPLETED | 100 μg Corifollitropin Alfa | 246 | |
| Overall Study | COMPLETED | 150 IU recFSH | 121 | |
| Overall Study | NOT COMPLETED | 100 μg Corifollitropin Alfa | 22 | |
| Overall Study | NOT COMPLETED | 150 IU recFSH | 8 |
Source ClinicalTrials.gov
Adverse events46
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 | Nasopharyngitis | Infections and infestations | 100 μg Corifollitropin Alfa | 13 | 268 | 13 |
| other | Nasopharyngitis | Infections and infestations | 150 IU recFSH | 7 | 129 | 7 |
| other | Headache | Nervous system disorders | 100 μg Corifollitropin Alfa | 25 | 268 | 30 |
| other | Headache | Nervous system disorders | 150 IU recFSH | 12 | 129 | 17 |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 100 μg Corifollitropin Alfa | 14 | 268 | 14 |
| other | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 150 IU recFSH | 8 | 129 | 8 |
| other | Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | 100 μg Corifollitropin Alfa | 18 | 268 | 22 |
| other | Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | 150 IU recFSH | 17 | 129 | 17 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | 100 μg Corifollitropin Alfa | 14 | 268 | 15 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | 150 IU recFSH | 6 | 129 | 7 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 μg Corifollitropin Alfa | ||
| Total, all-cause mortality | 150 IU recFSH | ||
| Total, other adverse events | 100 μg Corifollitropin Alfa | 107 | 268 |
| Total, other adverse events | 150 IU recFSH | 55 | 129 |
| Total, serious adverse events | 100 μg Corifollitropin Alfa | 20 | 268 |
| Total, serious adverse events | 150 IU recFSH | 9 | 129 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 100 μg Corifollitropin Alfa vs 150 IU recFSH: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00702845
GET https://conductscience.org/api/trials/v1/NCT00702845/results?page=2