Trial · NCT00703014
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
NCT00703014, Completed, Organon and Co; results first posted 2014-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712). Trials, record NCT00703014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
- NCT number
- NCT00703014
- Status
- Completed
- Enrollment
- 541 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Pregnancy, Neonates
- Interventions
Corifollitropin Alfa 150 μg, 200 IU RecFSH/Follitropin beta (Days 1 to 7), Placebo for Corifollitropin Alfa, Placebo for RecFSH/Follitropin beta, 200 IU RecFSH/Follitropin beta (Days 8 to hCG), Ganirelix, hCG, Progesterone
- First posted
- 2008-06-20
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2004-004772-36
- Results first posted
- 2014-11-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | Up to one day following delivery (up to 1 year) | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. |
| Primary | Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | Up to one day following delivery (up to 1 year) | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. |
| Primary | Number of Infants Born in Current Follow Up Trial Experiencing AEs | Up to 12 weeks following delivery (up to 1 year) | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. |
| Primary | Number of Infants in Current Follow Up Trial Experiencing SAEs | Up to 12 weeks following delivery (up to 1 year) | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. |
| Primary | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year) | The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial. |
| Primary | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year) | The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | Up to one day following delivery (up to 1 year) | Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Participants | NUMBER |
| PRIMARY | Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | Up to one day following delivery (up to 1 year) | Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Participants | NUMBER |
| PRIMARY | Number of Infants Born in Current Follow Up Trial Experiencing AEs | Up to 12 weeks following delivery (up to 1 year) | Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure. | Participants | NUMBER |
| PRIMARY | Number of Infants in Current Follow Up Trial Experiencing SAEs | Up to 12 weeks following delivery (up to 1 year) | Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure. | Participants | NUMBER |
| PRIMARY | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year) | Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year) | Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | Mothers Corifollitropin Alfa 150 µg | 222 | Participants | ||
| Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | Mothers recFSH 200 IU | 214 | Participants | ||
| Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | Mothers Corifollitropin Alfa 150 µg | 129 | Participants | ||
| Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | Mothers recFSH 200 IU | 117 | Participants | ||
| Number of Infants Born in Current Follow Up Trial Experiencing AEs | Infants Corifollitropin Alfa 150 µg | 164 | Participants | ||
| Number of Infants Born in Current Follow Up Trial Experiencing AEs | Infants recFSH 200 IU | 161 | Participants | ||
| Number of Infants in Current Follow Up Trial Experiencing SAEs | Infants Corifollitropin Alfa 150 µg | 106 | Participants | ||
| Number of Infants in Current Follow Up Trial Experiencing SAEs | Infants recFSH 200 IU | 94 | Participants | ||
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | Mothers Corifollitropin Alfa 150 µg | 35.6 | Percentage of Participants | ||
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | Mothers recFSH 200 IU | 34.4 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Mothers Base Trial P05787 (NCT00696800) | STARTED | Mothers Corifollitropin Alfa 150 µg | 757 | |
| Mothers Base Trial P05787 (NCT00696800) | STARTED | Mothers recFSH 200 IU | 752 | |
| Mothers Base Trial P05787 (NCT00696800) | STARTED | Fetuses/Infants Corifollitropin Alfa 150 µg | 0 | |
| Mothers Base Trial P05787 (NCT00696800) | STARTED | Fetuses/Infants recFSH 200 IU | 0 | |
| Mothers Base Trial P05787 (NCT00696800) | Treated | Mothers Corifollitropin Alfa 150 µg | 756 | |
| Mothers Base Trial P05787 (NCT00696800) | Treated | Mothers recFSH 200 IU | 750 | |
| Mothers Base Trial P05787 (NCT00696800) | Treated | Fetuses/Infants Corifollitropin Alfa 150 µg | 0 | |
| Mothers Base Trial P05787 (NCT00696800) | Treated | Fetuses/Infants recFSH 200 IU | 0 | |
| Mothers Base Trial P05787 (NCT00696800) | Embryo Transfer | Mothers Corifollitropin Alfa 150 µg | 672 | |
| Mothers Base Trial P05787 (NCT00696800) | Embryo Transfer | Mothers recFSH 200 IU | 704 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,140
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 | Anaemia | Blood and lymphatic system disorders | Mothers Corifollitropin Alfa 150 µg | 20 | 274 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Mothers recFSH 200 IU | 17 | 267 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Fetuses/Infants Corifollitropin Alfa 150 µg | 0 | 352 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Fetuses/Infants recFSH 200 IU | 0 | 326 | 0 |
| other | Constipation | Gastrointestinal disorders | Mothers Corifollitropin Alfa 150 µg | 15 | 274 | 16 |
| other | Constipation | Gastrointestinal disorders | Mothers recFSH 200 IU | 22 | 267 | 23 |
| other | Constipation | Gastrointestinal disorders | Fetuses/Infants Corifollitropin Alfa 150 µg | 2 | 352 | 2 |
| other | Constipation | Gastrointestinal disorders | Fetuses/Infants recFSH 200 IU | 8 | 326 | 8 |
| other | Dyspepsia | Gastrointestinal disorders | Mothers Corifollitropin Alfa 150 µg | 27 | 274 | 31 |
| other | Dyspepsia | Gastrointestinal disorders | Mothers recFSH 200 IU | 22 | 267 | 23 |
1 to 10 of 1,140Source ClinicalTrials.gov
See all 1,140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mothers Corifollitropin Alfa 150 µg | ||
| Total, all-cause mortality | Mothers recFSH 200 IU | ||
| Total, all-cause mortality | Fetuses/Infants Corifollitropin Alfa 150 µg | ||
| Total, all-cause mortality | Fetuses/Infants recFSH 200 IU | ||
| Total, other adverse events | Mothers Corifollitropin Alfa 150 µg | 112 | 274 |
| Total, other adverse events | Mothers recFSH 200 IU | 118 | 267 |
| Total, other adverse events | Fetuses/Infants Corifollitropin Alfa 150 µg | 37 | 352 |
| Total, other adverse events | Fetuses/Infants recFSH 200 IU | 41 | 326 |
| Total, serious adverse events | Mothers Corifollitropin Alfa 150 µg | 129 | 274 |
| Total, serious adverse events | Mothers recFSH 200 IU | 117 | 267 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mothers Corifollitropin Alfa 150 µg vs Mothers recFSH 200 IU: Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | Trial comparisons |
| Infants Corifollitropin Alfa 150 µg vs Infants recFSH 200 IU: Number of Infants Born in Current Follow Up Trial Experiencing AEs | Trial comparisons |
| Mothers Corifollitropin Alfa 150 µg vs Mothers recFSH 200 IU: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | Trial comparisons |
| Infants Corifollitropin Alfa 150 µg vs Infants recFSH 200 IU: Number of Infants in Current Follow Up Trial Experiencing SAEs | 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/NCT00703014
GET https://conductscience.org/api/trials/v1/NCT00703014/flow?page=2