Trial · NCT00565747
Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
NCT00565747, Phase 3, Completed, Origio A/S; results first posted 2013-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF. Trials, record NCT00565747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00565747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF
- NCT number
- NCT00565747
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,332 participants, actual
- Lead sponsor
- Origio A/S
- Conditions
- Infertility
- Interventions
- Test culture, Control culture
- First posted
- 2007-11-30
- Last updated
- 2015-05-15
- Results first posted
- 2013-11-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing Implantation Rate Week 7 | Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation) | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred. |
| Secondary | Number of Top Quality Embryos (TQE´s) | 3 days from oocyte pick-up | Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes. |
| Secondary | Live Birth | Until 7 days after birth | Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ongoing Implantation Rate Week 7 | Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation) | PP-population | percentage of transferred embryos | NUMBER |
| SECONDARY | Number of Top Quality Embryos (TQE´s) | 3 days from oocyte pick-up | PP-population | percentage of 2PN's | NUMBER |
| SECONDARY | Live Birth | Until 7 days after birth | PP-population | percentage of transfer patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ongoing Implantation Rate Week 7 | Test Culture | 23.5 | percentage of transferred embryos | ||
| Ongoing Implantation Rate Week 7 | Control Culture | 20.0 | percentage of transferred embryos | ||
| Number of Top Quality Embryos (TQE´s) | Test Culture | 15.6 | percentage of 2PN's | ||
| Number of Top Quality Embryos (TQE´s) | Control Culture | 16.8 | percentage of 2PN's | ||
| Live Birth | Test Culture | 28.9 | percentage of transfer patients | ||
| Live Birth | Control Culture | 24.1 | percentage of transfer patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Culture | 654 | |
| Overall Study | STARTED | Control Culture | 678 | |
| Overall Study | COMPLETED | Test Culture | 587 | |
| Overall Study | COMPLETED | Control Culture | 605 | |
| Overall Study | NOT COMPLETED | Test Culture | 67 | |
| Overall Study | NOT COMPLETED | Control Culture | 73 |
Source ClinicalTrials.gov
Adverse events16
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 | Miscarriage | Pregnancy, puerperium and perinatal conditions | Test Culture | 6 | 654 | 6 |
| other | Miscarriage | Pregnancy, puerperium and perinatal conditions | Control Culture | 6 | 678 | 6 |
| serious | Abdominal haemorrhage after oocyte pick-up. | Reproductive system and breast disorders | Test Culture | 0 | 654 | 0 |
| serious | Abdominal haemorrhage after oocyte pick-up. | Reproductive system and breast disorders | Control Culture | 1 | 678 | 1 |
| serious | Ovarian Hyperstimulation Syndrome | Reproductive system and breast disorders | Test Culture | 2 | 654 | 2 |
| serious | Ovarian Hyperstimulation Syndrome | Reproductive system and breast disorders | Control Culture | 1 | 678 | 1 |
| serious | Uterine retension, haematuria and cystitis | General disorders | Test Culture | 0 | 654 | 0 |
| serious | Uterine retension, haematuria and cystitis | General disorders | Control Culture | 1 | 678 | 1 |
| serious | Ovarian torsion | Reproductive system and breast disorders | Test Culture | 2 | 654 | 2 |
| serious | Ovarian torsion | Reproductive system and breast disorders | Control Culture | 0 | 678 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Culture | ||
| Total, all-cause mortality | Control Culture | ||
| Total, other adverse events | Test Culture | 6 | 654 |
| Total, other adverse events | Control Culture | 6 | 678 |
| Total, serious adverse events | Test Culture | 13 | 654 |
| Total, serious adverse events | Control Culture | 8 | 678 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| Test Culture vs Control Culture: 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/NCT00565747
GET https://conductscience.org/api/trials/v1/NCT00565747/registered