Trial · NCT00696800
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
NCT00696800, Phase 3, Completed, Organon and Co; results first posted 2014-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787). Trials, record NCT00696800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00696800
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
- NCT number
- NCT00696800
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,509 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- In Vitro Fertilization
- Interventions
- Corifollitropin alfa, RecFSH / Follitropin beta (Days 1 to 7), Placebo Corifollitropin alfa, Placebo RecFSH / follitropin beta, RecFSH / Follitropin beta (Days 8 to hCG), Ganirelix, hCG, Progesterone
- First posted
- 2008-06-13
- Last updated
- 2024-06-20
- Other registries' IDs
- eudract:2004-004771-11
- Results first posted
- 2014-08-21
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | Assessed at least 10 weeks after embryo transfer (up to 1 year) | An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant. |
| Primary | Mean Number of Oocytes Retrieved | Up to 36 hours after administration of hCG (up to 1 year) | Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed. |
| Secondary | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | From Day 1 to day of hCG treatment (up to 1 year) | The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards. |
| Secondary | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | From Day 8 to Day of hCG treatment (up to 1 year) | The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards. |
| Secondary | Serum FSH Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Secondary | Serum Luteinizing Hormone (LH) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Secondary | Serum Estradiol (E2) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment. |
| Secondary | Serum Progesterone (P) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment |
| Secondary | Serum Inhibin-B Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment |
| Secondary | Number of Follicles Categorized by Size on Stimulation Day 1 | On Day 1 of treatment (up to 1 year) | Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
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 an Ongoing Pregnancy (Ongoing Pregnancy Rate) | Assessed at least 10 weeks after embryo transfer (up to 1 year) | Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. | Percentage of participants | NUMBER |
| PRIMARY | Mean Number of Oocytes Retrieved | Up to 36 hours after administration of hCG (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. | Number of oocytes | MEAN |
| SECONDARY | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | From Day 1 to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection. | IU | MEDIAN |
| SECONDARY | Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | From Day 8 to Day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection. | IU | MEDIAN |
| SECONDARY | Serum FSH Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available. | IU/L | MEAN |
| SECONDARY | Serum Luteinizing Hormone (LH) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available. | IU/L | MEAN |
| SECONDARY | Serum Estradiol (E2) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available. | pmol/L | MEAN |
| SECONDARY | Serum Progesterone (P) Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available. | nmol/mL | MEAN |
| SECONDARY | Serum Inhibin-B Levels During Stimulation | Up to day of hCG treatment (up to 1 year) | ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available. | pg/mL | MEAN |
| SECONDARY | Number of Follicles Categorized by Size on Stimulation Day 1 | On Day 1 of treatment (up to 1 year) | ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1. | Number of follicles | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group110
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 an Ongoing Pregnancy (Ongoing Pregnancy Rate) | 150 µg Corifollitropin Alfa | 39.0 | Percentage of participants | ||
| Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | 200 IU recFSH | 38.1 | Percentage of participants | ||
| Mean Number of Oocytes Retrieved | 150 µg Corifollitropin Alfa | 13.8 | Standard Deviation 8.3 | Number of oocytes | |
| Mean Number of Oocytes Retrieved | 200 IU recFSH | 12.6 | Standard Deviation 6.8 | Number of oocytes | |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | 150 µg Corifollitropin Alfa | 400 | Full Range 0 to 2000 | IU | |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1 | 200 IU recFSH | 1800 | Full Range 400 to 2800 | IU | |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | 150 µg Corifollitropin Alfa | 400 | Full Range 0 to 2000 | IU | |
| Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8 | 200 IU recFSH | 400 | Full Range 0 to 1400 | IU | |
| Serum FSH Levels During Stimulation | 150 µg Corifollitropin Alfa | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 6.70 | Standard Deviation 2.05 | IU/L |
| Serum FSH Levels During Stimulation | 200 IU recFSH | Day 1 (Pre-dose) (Cori. Alfa N=732; recFSH N=724) | 6.60 | Standard Deviation 1.86 | IU/L |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 150 µg Corifollitropin Alfa | 757 | |
| Overall Study | STARTED | 200 IU recFSH | 752 | |
| Overall Study | Treated (ITT) | 150 µg Corifollitropin Alfa | 756 | |
| Overall Study | Treated (ITT) | 200 IU recFSH | 750 | |
| Overall Study | COMPLETED | 150 µg Corifollitropin Alfa | 672 | |
| Overall Study | COMPLETED | 200 IU recFSH | 704 | |
| Overall Study | NOT COMPLETED | 150 µg Corifollitropin Alfa | 85 | |
| Overall Study | NOT COMPLETED | 200 IU recFSH | 48 |
Source ClinicalTrials.gov
Adverse events76
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 | 150 µg Corifollitropin Alfa | 77 | 755 | 81 |
| other | Nausea | Gastrointestinal disorders | 200 IU recFSH | 82 | 751 | 100 |
| other | Fatigue | General disorders | 150 µg Corifollitropin Alfa | 43 | 755 | 47 |
| other | Fatigue | General disorders | 200 IU recFSH | 37 | 751 | 41 |
| other | Post procedural complication | Injury, poisoning and procedural complications | 150 µg Corifollitropin Alfa | 53 | 755 | 65 |
| other | Post procedural complication | Injury, poisoning and procedural complications | 200 IU recFSH | 52 | 751 | 59 |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | 150 µg Corifollitropin Alfa | 43 | 755 | 47 |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | 200 IU recFSH | 43 | 751 | 46 |
| other | Procedural pain | Injury, poisoning and procedural complications | 150 µg Corifollitropin Alfa | 173 | 755 | 182 |
| other | Procedural pain | Injury, poisoning and procedural complications | 200 IU recFSH | 157 | 751 | 169 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 150 µg Corifollitropin Alfa | ||
| Total, all-cause mortality | 200 IU recFSH | ||
| Total, other adverse events | 150 µg Corifollitropin Alfa | 403 | 755 |
| Total, other adverse events | 200 IU recFSH | 383 | 751 |
| Total, serious adverse events | 150 µg Corifollitropin Alfa | 35 | 755 |
| Total, serious adverse events | 200 IU recFSH | 30 | 751 |
Source ClinicalTrials.gov
Papers7
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 |
|---|
| 150 µg Corifollitropin Alfa vs 200 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/NCT00696800
GET https://conductscience.org/api/trials/v1/NCT00696800/registered?page=2