Trial · NCT00505752
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
NCT00505752, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2013-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART). Trials, record NCT00505752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00505752
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
- NCT number
- NCT00505752
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 520 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility
- Interventions
- AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg, Follitropin alfa 150 international unit (IU), Recombinant human chorionic gonadotropin (r-hCG)
- First posted
- 2007-07-23
- Last updated
- 2014-02-13
- Results first posted
- 2013-07-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. |
| Secondary | Percentage of Participants With Clinical Pregnancy | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) | Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Fertilized Oocytes (2 Pronuclei [PN]) | Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}]) | Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | 2PN oocytes | MEAN |
| SECONDARY | Percentage of Participants With Clinical Pregnancy | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) | ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | AS900672-Enriched 50 Mcg | 7.0 | Standard Deviation 4.7 | 2PN oocytes | |
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | AS900672-Enriched 100 Microgram (Mcg) | 8.7 | Standard Deviation 4.9 | 2PN oocytes | |
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | AS900672-Enriched 150 Microgram (Mcg) | 9.2 | Standard Deviation 6.0 | 2PN oocytes | |
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | Follitropin Alfa 150 IU | 6.7 | Standard Deviation 4.2 | 2PN oocytes | |
| Percentage of Participants With Clinical Pregnancy | AS900672-Enriched 50 Mcg | 39.1 | Percentage of participants | ||
| Percentage of Participants With Clinical Pregnancy | AS900672-Enriched 100 Microgram (Mcg) | 40.8 | Percentage of participants | ||
| Percentage of Participants With Clinical Pregnancy | AS900672-Enriched 150 Microgram (Mcg) | 35.2 | Percentage of participants | ||
| Percentage of Participants With Clinical Pregnancy | Follitropin Alfa 150 IU | 43.8 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AS900672-Enriched 50 Mcg | 132 | |
| Overall Study | STARTED | AS900672-Enriched 100 Microgram (Mcg) | 128 | |
| Overall Study | STARTED | AS900672-Enriched 150 Microgram (Mcg) | 128 | |
| Overall Study | STARTED | Follitropin Alfa 150 IU | 132 | |
| Overall Study | COMPLETED | AS900672-Enriched 50 Mcg | 126 | |
| Overall Study | COMPLETED | AS900672-Enriched 100 Microgram (Mcg) | 119 | |
| Overall Study | COMPLETED | AS900672-Enriched 150 Microgram (Mcg) | 120 | |
| Overall Study | COMPLETED | Follitropin Alfa 150 IU | 126 | |
| Overall Study | NOT COMPLETED | AS900672-Enriched 50 Mcg | 6 | |
| Overall Study | NOT COMPLETED | AS900672-Enriched 100 Microgram (Mcg) | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Procedural pain | Injury, poisoning and procedural complications | AS900672-Enriched 50 Mcg | 35 | 132 | |
| other | Procedural pain | Injury, poisoning and procedural complications | AS900672-Enriched 100 Microgram (Mcg) | 29 | 128 | |
| other | Procedural pain | Injury, poisoning and procedural complications | AS900672-Enriched 150 Microgram (Mcg) | 27 | 128 | |
| other | Procedural pain | Injury, poisoning and procedural complications | Follitropin Alfa 150 IU | 39 | 132 | |
| other | Headache | Nervous system disorders | AS900672-Enriched 50 Mcg | 23 | 132 | |
| other | Headache | Nervous system disorders | AS900672-Enriched 100 Microgram (Mcg) | 22 | 128 | |
| other | Headache | Nervous system disorders | AS900672-Enriched 150 Microgram (Mcg) | 22 | 128 | |
| other | Headache | Nervous system disorders | Follitropin Alfa 150 IU | 28 | 132 | |
| other | Abdominal distension | Gastrointestinal disorders | AS900672-Enriched 50 Mcg | 15 | 132 | |
| other | Abdominal distension | Gastrointestinal disorders | AS900672-Enriched 100 Microgram (Mcg) | 16 | 128 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AS900672-Enriched 50 Mcg | ||
| Total, all-cause mortality | AS900672-Enriched 100 Microgram (Mcg) | ||
| Total, all-cause mortality | AS900672-Enriched 150 Microgram (Mcg) | ||
| Total, all-cause mortality | Follitropin Alfa 150 IU | ||
| Total, other adverse events | AS900672-Enriched 50 Mcg | 90 | 132 |
| Total, other adverse events | AS900672-Enriched 100 Microgram (Mcg) | 85 | 128 |
| Total, other adverse events | AS900672-Enriched 150 Microgram (Mcg) | 84 | 128 |
| Total, other adverse events | Follitropin Alfa 150 IU | 82 | 132 |
| Total, serious adverse events | AS900672-Enriched 50 Mcg | 5 | 132 |
| Total, serious adverse events | AS900672-Enriched 100 Microgram (Mcg) | 5 | 128 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT00505752
GET https://conductscience.org/api/trials/v1/NCT00505752/events?page=2