Trial · NCT01144416
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
NCT01144416, Phase 3, Completed, Organon and Co; results first posted 2012-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029). Trials, record NCT01144416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01144416
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
- NCT number
- NCT01144416
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,424 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Infertility
- Interventions
- SCH 900962 / Corifollitropin alfa / Org 36286, RecFSH / follitropin beta, Placebo for SCH 900962, Placebo for recFSH
- First posted
- 2010-06-15
- Last updated
- 2022-02-03
- Results first posted
- 2012-12-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Vital Pregnancy | 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 |
| Secondary | Number of Oocytes Retrieved Per Attempt | Maximally 21 days after the start of study treatment. | The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle). |
| Secondary | Live Birth Rate | Approximately nine months after embryo transfer | 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. |
| Secondary | Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) | Up to approximately 1 month after oocyte pick-up | 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. |
| Secondary | 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) | The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups. |
Source ClinicalTrials.gov
Outcomes5
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 a Vital Pregnancy | 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. | 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. | percentage of participants | NUMBER |
| SECONDARY | Number of Oocytes Retrieved Per Attempt | Maximally 21 days after the start of study treatment. | Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval. | Number of oocytes | MEAN |
| SECONDARY | Live Birth Rate | Approximately nine months after embryo transfer | 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. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) | Up to approximately 1 month after oocyte pick-up | All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. | participants | NUMBER |
| SECONDARY | 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) | All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
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 a Vital Pregnancy | Single Injection of 150 µg SCH 900962/MK-8962 | 23.9 | percentage of participants | ||
| Percentage of Participants With a Vital Pregnancy | Daily 300 IU recFSH | 26.9 | percentage of participants | ||
| Number of Oocytes Retrieved Per Attempt | Single Injection of 150 µg SCH 900962/MK-8962 | 10.7 | Standard Deviation 7.2 | Number of oocytes | |
| Number of Oocytes Retrieved Per Attempt | Daily 300 IU recFSH | 10.3 | Standard Deviation 6.8 | Number of oocytes | |
| Live Birth Rate | Single Injection of 150 µg SCH 900962/MK-8962 | 21.3 | Percentage of participants | ||
| Live Birth Rate | Daily 300 IU recFSH | 23.4 | Percentage of participants | ||
| Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) | Single Injection of 150 µg SCH 900962/MK-8962 | 5 | participants | ||
| Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) | Daily 300 IU recFSH | 10 | participants | ||
| Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event | Single Injection of 150 µg SCH 900962/MK-8962 | 5 | participants | ||
| Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event | Daily 300 IU recFSH | 6 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention Period | STARTED | Single Injection of 150 µg SCH 900962/MK-8962 | 694 | |
| Intervention Period | STARTED | Daily 300 IU recFSH | 696 | |
| Intervention Period | COMPLETED | Single Injection of 150 µg SCH 900962/MK-8962 | 632 | |
| Intervention Period | COMPLETED | Daily 300 IU recFSH | 647 | |
| Intervention Period | NOT COMPLETED | Single Injection of 150 µg SCH 900962/MK-8962 | 62 | |
| Intervention Period | NOT COMPLETED | Daily 300 IU recFSH | 49 | |
| Pregnancy Follow-up Period | STARTED | Single Injection of 150 µg SCH 900962/MK-8962 | 154 | |
| Pregnancy Follow-up Period | STARTED | Daily 300 IU recFSH | 167 | |
| Pregnancy Follow-up Period | COMPLETED | Single Injection of 150 µg SCH 900962/MK-8962 | 146 | |
| Pregnancy Follow-up Period | COMPLETED | Daily 300 IU recFSH | 157 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events724
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 | NAUSEA | Gastrointestinal disorders | Single Injection of 150 µg SCH 900962/MK-8962 | 47 | 692 | 50 |
| other | NAUSEA | Gastrointestinal disorders | Daily 300 IU recFSH | 33 | 698 | 36 |
| other | NAUSEA | Gastrointestinal disorders | Single Injection of 150 µg SCH 900962/MK-8962-Follow-up | 10 | 154 | 10 |
| other | NAUSEA | Gastrointestinal disorders | Daily 300 IU recFSH -Follow-up | 15 | 167 | 15 |
| other | POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | Single Injection of 150 µg SCH 900962/MK-8962 | 61 | 692 | 64 |
| other | POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | Daily 300 IU recFSH | 69 | 698 | 72 |
| other | POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | Single Injection of 150 µg SCH 900962/MK-8962-Follow-up | 5 | 154 | 7 |
| other | POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | Daily 300 IU recFSH -Follow-up | 4 | 167 | 4 |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | Single Injection of 150 µg SCH 900962/MK-8962 | 98 | 692 | 101 |
| other | PROCEDURAL PAIN | Injury, poisoning and procedural complications | Daily 300 IU recFSH | 83 | 698 | 86 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Injection of 150 µg SCH 900962/MK-8962 | ||
| Total, all-cause mortality | Daily 300 IU recFSH | ||
| Total, all-cause mortality | Single Injection of 150 µg SCH 900962/MK-8962-Follow-up | ||
| Total, all-cause mortality | Daily 300 IU recFSH -Follow-up | ||
| Total, other adverse events | Single Injection of 150 µg SCH 900962/MK-8962 | 267 | 692 |
| Total, other adverse events | Daily 300 IU recFSH | 262 | 698 |
| Total, other adverse events | Single Injection of 150 µg SCH 900962/MK-8962-Follow-up | 94 | 154 |
| Total, other adverse events | Daily 300 IU recFSH -Follow-up | 105 | 167 |
| Total, serious adverse events | Single Injection of 150 µg SCH 900962/MK-8962 | 4 | 692 |
| Total, serious adverse events | Daily 300 IU recFSH | 19 | 698 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Single Injection of 150 µg SCH 900962/MK-8962 vs Daily 300 IU recFSH: Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event | Trial comparisons |
| Single Injection of 150 µg SCH 900962/MK-8962 vs Daily 300 IU recFSH: Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) | 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/NCT01144416
GET https://conductscience.org/api/trials/v1/NCT01144416/events?page=2