Trial · NCT01112358
Lutropin Alfa in Women at Risk of Poor Response
NCT01112358, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lutropin Alfa in Women at Risk of Poor Response. Trials, record NCT01112358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01112358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lutropin Alfa in Women at Risk of Poor Response
- NCT number
- NCT01112358
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Ovarian Stimulation
- Interventions
- r-FSH, r-hLH, Analogous GnRH antagonist, r-hCG, Progesterone
- First posted
- 2010-04-28
- Last updated
- 2018-08-28
- Other registries' IDs
- eudract:2005-002229-30
- Results first posted
- 2018-07-30
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | At the end of stimulation (Day 2 up to Day 8) | |
| Primary | Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | At the end of stimulation (Day 2 up to Day 8) | |
| Primary | Oocytes Recovery Rate | At the end of stimulation (Day 2 up to Day 8) | Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter. |
| Secondary | Oocyte Nuclear Maturity Rate | At the end of stimulation (Day 2 up to Day 8) | Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved. |
| Secondary | Fertilization Rate | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | The fertilization rate (2 pronuclei \[PN\] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes. |
| Secondary | Number of Embryos by Quality | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (\>50%). |
| Secondary | Number of Embryos Transferred by In Vitro Fertilization (IVF) | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | |
| Secondary | Number of Participants With Positive Pregnancy Test | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. |
| Secondary | Number of Participants With Clinical Pregnancy | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac). |
| Secondary | Implementation Rate | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oocytes Retrieved | At the end of stimulation (Day 2 up to Day 8) | ITT population | Oocytes | MEAN |
| PRIMARY | Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | At the end of stimulation (Day 2 up to Day 8) | ITT population | Follicles | MEAN |
| PRIMARY | Oocytes Recovery Rate | At the end of stimulation (Day 2 up to Day 8) | ITT population | oocytes per >14 mm follicle | MEAN |
| SECONDARY | Oocyte Nuclear Maturity Rate | At the end of stimulation (Day 2 up to Day 8) | ITT population | metaphase II oocytes/retrieved oocyte | MEAN |
| SECONDARY | Fertilization Rate | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | 2PN fertilized oocyte/inseminated oocyte | MEAN |
| SECONDARY | Number of Embryos by Quality | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | Embroys | MEAN |
| SECONDARY | Number of Embryos Transferred by In Vitro Fertilization (IVF) | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | Embroys | MEAN |
| SECONDARY | Number of Participants With Positive Pregnancy Test | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Pregnancy | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | Participants | NUMBER |
| SECONDARY | Implementation Rate | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) | ITT population | Clinical pregnancy/embryo transferred | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Oocytes Retrieved | r-FSH + r-hLH | 4.0 | Standard Deviation 5.3 | Oocytes | |
| Number of Oocytes Retrieved | r-FSH | 3.5 | Standard Deviation 3.1 | Oocytes | |
| Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | r-FSH + r-hLH | 7.2 | Standard Deviation 1.1 | Follicles | |
| Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | r-FSH | 7.0 | Standard Deviation 0.8 | Follicles | |
| Oocytes Recovery Rate | r-FSH + r-hLH | 0.56 | Standard Deviation 0.42 | oocytes per >14 mm follicle | |
| Oocytes Recovery Rate | r-FSH | 0.50 | Standard Deviation 0.41 | oocytes per >14 mm follicle | |
| Oocyte Nuclear Maturity Rate | r-FSH + r-hLH | 0.73 | Standard Deviation 0.75 | metaphase II oocytes/retrieved oocyte | |
| Oocyte Nuclear Maturity Rate | r-FSH | 0.61 | Standard Deviation 0.26 | metaphase II oocytes/retrieved oocyte | |
| Fertilization Rate | r-FSH + r-hLH | 0.70 | Standard Deviation 0.35 | 2PN fertilized oocyte/inseminated oocyte | |
| Fertilization Rate | r-FSH | 0.64 | Standard Deviation 0.33 | 2PN fertilized oocyte/inseminated oocyte |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | r-FSH + r-hLH | 25 | |
| Overall Study | STARTED | r-FSH | 33 | |
| Overall Study | COMPLETED | r-FSH + r-hLH | 25 | |
| Overall Study | COMPLETED | r-FSH | 33 | |
| Overall Study | NOT COMPLETED | r-FSH + r-hLH | 0 | |
| Overall Study | NOT COMPLETED | r-FSH | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | r-FSH + r-hLH | ||
| Total, all-cause mortality | r-FSH | ||
| Total, other adverse events | r-FSH + r-hLH | 0 | 25 |
| Total, other adverse events | r-FSH | 0 | 33 |
| Total, serious adverse events | r-FSH + r-hLH | 0 | 25 |
| Total, serious adverse events | r-FSH | 0 | 33 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| r-FSH + r-hLH vs r-FSH: Number of Participants With Positive Pregnancy Test | Trial comparisons |
| r-FSH + r-hLH vs r-FSH: Number of Participants With Clinical Pregnancy | Trial comparisons |
| r-FSH + r-hLH vs r-FSH: Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled | Trial comparisons |
| r-FSH + r-hLH vs r-FSH: serious adverse events | 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/NCT01112358
GET https://conductscience.org/api/trials/v1/NCT01112358/results?page=2