Trial · NCT00702234
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
NCT00702234, Completed, Organon and Co; results first posted 2015-04-27
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 P05714 (Care Program)(P05715). Trials, record NCT00702234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00702234
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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 P05714 (Care Program)(P05715)
- NCT number
- NCT00702234
- Status
- Completed
- Enrollment
- 268 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Pregnancy, Neonates
- Interventions
- Corifollitropin alfa, GnRH antagonist, (rec)hCG, FSH, Progesterone
- First posted
- 2008-06-20
- Last updated
- 2024-09-05
- Other registries' IDs
- eudract:2004-004967-30
- Results first posted
- 2015-04-27
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 Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) | Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) | The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants. |
| Primary | Number of Expectant Mothers Experiencing Adverse Events (AEs) | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) | 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 Expectant Mothers Experiencing Serious AEs (SAEs) | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) | 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. |
| Primary | Number of Live Born Infants Experiencing AEs | Up to 12 weeks after birth | 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 Live Born Infants Experiencing SAEs | Up to 12 weeks after birth | 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. |
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 Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) | Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) | Participants administered corifollitropin alfa in base study P05714 (NCT00696878) | percentage of participants | NUMBER |
| PRIMARY | Number of Expectant Mothers Experiencing Adverse Events (AEs) | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | participants | NUMBER |
| PRIMARY | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | participants | NUMBER |
| PRIMARY | Number of Live Born Infants Experiencing AEs | Up to 12 weeks after birth | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | participants | NUMBER |
| PRIMARY | Number of Live Born Infants Experiencing SAEs | Up to 12 weeks after birth | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) | Women - Corifollitropin Alfa 150 µg | 37.8 | percentage of participants | ||
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | Expectant Mothers - Corifollitropin Alfa 150 µg | 203 | participants | ||
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | Expectant Mothers - Corifollitropin Alfa 150 µg | 145 | participants | ||
| Number of Live Born Infants Experiencing AEs | Live Born Infants | 99 | participants | ||
| Number of Live Born Infants Experiencing SAEs | Live Born Infants | 79 | participants |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study (NCT00696878) | STARTED | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | 682 | |
| Base Study (NCT00696878) | STARTED | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | |
| Base Study (NCT00696878) | COMPLETED | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | 178 | |
| Base Study (NCT00696878) | COMPLETED | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | |
| Base Study (NCT00696878) | NOT COMPLETED | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | 504 | |
| Base Study (NCT00696878) | NOT COMPLETED | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | |
| Follow-up Study: Expectant Mothers | STARTED | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | 268 | |
| Follow-up Study: Expectant Mothers | STARTED | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | |
| Follow-up Study: Expectant Mothers | COMPLETED | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | 246 | |
| Follow-up Study: Expectant Mothers | COMPLETED | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events298
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Expectant Mothers - Corifollitropin Alfa 150 µg | 1 | 268 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | 315 | 0 |
| serious | Anaemia neonatal | Blood and lymphatic system disorders | Expectant Mothers - Corifollitropin Alfa 150 µg | 0 | 268 | 0 |
| serious | Anaemia neonatal | Blood and lymphatic system disorders | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 3 | 315 | 3 |
| serious | Disseminated intravascular coagulation in newborn | Blood and lymphatic system disorders | Expectant Mothers - Corifollitropin Alfa 150 µg | 0 | 268 | 0 |
| serious | Disseminated intravascular coagulation in newborn | Blood and lymphatic system disorders | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 1 | 315 | 1 |
| serious | Bradycardia foetal | Cardiac disorders | Expectant Mothers - Corifollitropin Alfa 150 µg | 1 | 268 | 1 |
| serious | Bradycardia foetal | Cardiac disorders | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 1 | 315 | 1 |
| serious | Bradycardia neonatal | Cardiac disorders | Expectant Mothers - Corifollitropin Alfa 150 µg | 0 | 268 | 0 |
| serious | Bradycardia neonatal | Cardiac disorders | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 1 | 315 | 1 |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Expectant Mothers - Corifollitropin Alfa 150 µg | ||
| Total, all-cause mortality | Fetuses Present at 10 Weeks After Fresh ET in Base Study | ||
| Total, other adverse events | Expectant Mothers - Corifollitropin Alfa 150 µg | 0 | 268 |
| Total, other adverse events | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 0 | 315 |
| Total, serious adverse events | Expectant Mothers - Corifollitropin Alfa 150 µg | 145 | 268 |
| Total, serious adverse events | Fetuses Present at 10 Weeks After Fresh ET in Base Study | 84 | 315 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22587997 | DERIVED |
Source PubMed
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 |
|---|
| Expectant Mothers - Corifollitropin Alfa 150 µg vs Fetuses Present at 10 Weeks After Fresh ET in Base Study: 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/NCT00702234
GET https://conductscience.org/api/trials/v1/NCT00702234/events?page=2