Trial · NCT01044862
Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
NCT01044862, Phase 3, Completed, Yale University; results first posted 2015-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. Trials, record NCT01044862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01044862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
- NCT number
- NCT01044862
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 900 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Pregnancy, Unexplained Infertility
- Interventions
- Letrozole (aromatase inhibitor), Clomiphene Citrate, Follicle Stimulating Hormone (gonadotropin)
- First posted
- 2010-01-08
- Last updated
- 2015-02-02
- Results first posted
- 2015-02-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | |
| Secondary | Rate of Pregnancy Obtained | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | |
| Secondary | Time to Pregnancy | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | |
| Secondary | Live Birth Rate | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | number of multiples | NUMBER | |
| SECONDARY | Rate of Pregnancy Obtained | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | participants | NUMBER | |
| SECONDARY | Time to Pregnancy | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | days | MEAN | |
| SECONDARY | Live Birth Rate | Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks | 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 |
|---|---|---|---|---|---|
| Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. | Aromatase Inhibitors (AI) | 9 | number of multiples | ||
| Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. | Clomiphene Citrate (CC) | 8 | number of multiples | ||
| Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. | Follicle Stimulating Hormone (FSH) | 34 | number of multiples | ||
| Rate of Pregnancy Obtained | Aromatase Inhibitors (AI) | 85 | participants | ||
| Rate of Pregnancy Obtained | Clomiphene Citrate (CC) | 106 | participants | ||
| Rate of Pregnancy Obtained | Follicle Stimulating Hormone (FSH) | 140 | participants | ||
| Time to Pregnancy | Aromatase Inhibitors (AI) | 67.2 | Standard Deviation 55.6 | days | |
| Time to Pregnancy | Clomiphene Citrate (CC) | 67.4 | Standard Deviation 49.8 | days | |
| Time to Pregnancy | Follicle Stimulating Hormone (FSH) | 62.3 | Standard Deviation 43.8 | days | |
| Live Birth Rate | Aromatase Inhibitors (AI) | 56 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aromatase Inhibitors (AI) | 299 | |
| Overall Study | STARTED | Clomiphene Citrate (CC) | 300 | |
| Overall Study | STARTED | Follicle Stimulating Hormone (FSH) | 301 | |
| Overall Study | COMPLETED | Aromatase Inhibitors (AI) | 246 | |
| Overall Study | COMPLETED | Clomiphene Citrate (CC) | 251 | |
| Overall Study | COMPLETED | Follicle Stimulating Hormone (FSH) | 249 | |
| Overall Study | NOT COMPLETED | Aromatase Inhibitors (AI) | 53 | |
| Overall Study | NOT COMPLETED | Clomiphene Citrate (CC) | 49 | |
| Overall Study | NOT COMPLETED | Follicle Stimulating Hormone (FSH) | 52 |
Source ClinicalTrials.gov
Adverse events72
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 | Abdominal Bloating | Gastrointestinal disorders | Aromatase Inhibitors (AI) | 54 | 291 | 54 |
| other | Abdominal Bloating | Gastrointestinal disorders | Clomiphene Citrate (CC) | 50 | 298 | 50 |
| other | Abdominal Bloating | Gastrointestinal disorders | Follicle Stimulating Hormone (FSH) | 81 | 297 | 81 |
| other | Breast Pain | Reproductive system and breast disorders | Aromatase Inhibitors (AI) | 26 | 291 | 26 |
| other | Breast Pain | Reproductive system and breast disorders | Clomiphene Citrate (CC) | 19 | 298 | 19 |
| other | Breast Pain | Reproductive system and breast disorders | Follicle Stimulating Hormone (FSH) | 65 | 297 | 65 |
| other | Constipation | Gastrointestinal disorders | Aromatase Inhibitors (AI) | 8 | 291 | 8 |
| other | Constipation | Gastrointestinal disorders | Clomiphene Citrate (CC) | 28 | 298 | 28 |
| other | Constipation | Gastrointestinal disorders | Follicle Stimulating Hormone (FSH) | 6 | 297 | 6 |
| other | Headache | Nervous system disorders | Aromatase Inhibitors (AI) | 122 | 291 | 122 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aromatase Inhibitors (AI) | ||
| Total, all-cause mortality | Clomiphene Citrate (CC) | ||
| Total, all-cause mortality | Follicle Stimulating Hormone (FSH) | ||
| Total, other adverse events | Aromatase Inhibitors (AI) | 218 | 291 |
| Total, other adverse events | Clomiphene Citrate (CC) | 214 | 298 |
| Total, other adverse events | Follicle Stimulating Hormone (FSH) | 217 | 297 |
| Total, serious adverse events | Aromatase Inhibitors (AI) | 11 | 291 |
| Total, serious adverse events | Clomiphene Citrate (CC) | 12 | 298 |
| Total, serious adverse events | Follicle Stimulating Hormone (FSH) | 25 | 297 |
Source ClinicalTrials.gov
Papers22
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HD055925 | Data Coordination Center for the RMN | ZHANG, HEPING | YALE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2007 to 2019 | NIH RePORTER |
| U10HD039005 | GHSU/WSU Cooperative Reproductive Medicine Network | DIAMOND, MICHAEL PETER | AUGUSTA UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2000 to 2017 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01044862
GET https://conductscience.org/api/trials/v1/NCT01044862/events?page=2