Trial · NCT01071200
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
NCT01071200, Phase 3, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2012-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle. Trials, record NCT01071200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01071200
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
- NCT number
- NCT01071200
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Reproductive Techniques, Assisted
- Interventions
- Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH), r-hFSH
- First posted
- 2010-02-19
- Last updated
- 2013-12-27
- Other registries' IDs
- eudract:2004-002218-13
- Results first posted
- 2012-08-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | Baseline (Stimulation day 8 [S8]) until hCG day | |
| Secondary | Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | Baseline (S8) until hCG day | |
| Secondary | Mean Number of Ovarian Stimulation Days | Baseline (S8) until hCG day | |
| Secondary | Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day | Baseline (S8) and hCG day | |
| Secondary | Mean Total Number of Retrieved Oocytes | 34-36 hours post-hCG (OPU) | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. |
| Secondary | Mean Number of Mature Oocytes (Metaphase II) | 34-36 hours post-hCG (OPU) | Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes. |
| Secondary | Fertilization Rate | 12-18 day post-hCG and/or Week 7 | Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3). |
| Secondary | Number of Obtained Embryos | Day 3 post-hCG (Embryo transfer [ET]) | Total number of obtained embryos with maximum 3 inseminated oocytes was calculated. |
| Secondary | Number of Transferred Embryos | Day 3 post-hCG (ET) | Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube. |
| Secondary | Percentage of Participants With Pregnancy | 12-18 day post-hCG and/or Week 7 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | Baseline (Stimulation day 8 [S8]) until hCG day | Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed for this measure. | IU | MEAN |
| SECONDARY | Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | Baseline (S8) until hCG day | mITT population included all randomized participants who entered in the experimental phase at S8. | IU | MEAN |
| SECONDARY | Mean Number of Ovarian Stimulation Days | Baseline (S8) until hCG day | mITT population included all randomized participants who entered in the experimental phase at S8. | Days | MEAN |
| SECONDARY | Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day | Baseline (S8) and hCG day | mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed and n represents the number of participants with plasma E2 levels at specified time points for respective treatment groups. | picogram/milliter (pg/mL) | MEAN |
| SECONDARY | Mean Total Number of Retrieved Oocytes | 34-36 hours post-hCG (OPU) | mITT population included all randomized participants who entered in the experimental phase at S8. | oocytes | MEAN |
| SECONDARY | Mean Number of Mature Oocytes (Metaphase II) | 34-36 hours post-hCG (OPU) | mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope. | Metaphase II Oocytes | MEAN |
| SECONDARY | Fertilization Rate | 12-18 day post-hCG and/or Week 7 | mITT population included all randomized participants who entered in the experimental phase at S8. | ratio | MEAN |
| SECONDARY | Number of Obtained Embryos | Day 3 post-hCG (Embryo transfer [ET]) | mITT population included all randomized participants who entered in the experimental phase at S8. | embryos | NUMBER |
| SECONDARY | Number of Transferred Embryos | Day 3 post-hCG (ET) | mITT population included all randomized participants who entered in the experimental phase at S8. | embryos | NUMBER |
| SECONDARY | Percentage of Participants With Pregnancy | 12-18 day post-hCG and/or Week 7 | mITT population included all randomized participants who entered in the experimental phase at S8. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | FSH + rhLH | Baseline (S8) | 904.6 | Standard Deviation 1068.1 | IU |
| Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | Follicle-stimulating Hormone (FSH) | Baseline (S8) | 703.3 | Standard Deviation 924.5 | IU |
| Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | FSH + rhLH | Baseline (S8) until hCG day | 388.5 | Standard Deviation 631.3 | IU |
| Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes | Follicle-stimulating Hormone (FSH) | Baseline (S8) until hCG day | 318.5 | Standard Deviation 534.0 | IU |
| Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | FSH + rhLH | Total FSH dose | 1434.0 | Standard Deviation 678.1 | IU |
| Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | Follicle-stimulating Hormone (FSH) | Total FSH dose | 1595.0 | Standard Deviation 796.4 | IU |
| Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | FSH + rhLH | Total r-hLH dose | 575.9 | Standard Deviation 273.0 | IU |
| Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose | Follicle-stimulating Hormone (FSH) | Total r-hLH dose | 0 | Standard Deviation 0 | IU |
| Mean Number of Ovarian Stimulation Days | FSH + rhLH | 4.6 | Full Range 2.0 to 10.0 | Days | |
| Mean Number of Ovarian Stimulation Days | Follicle-stimulating Hormone (FSH) | 4.8 | Full Range 1.0 to 9.0 | Days |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FSH + rhLH | 67 | |
| Overall Study | STARTED | Follicle-stimulating Hormone (FSH) | 66 | |
| Overall Study | COMPLETED | FSH + rhLH | 60 | |
| Overall Study | COMPLETED | Follicle-stimulating Hormone (FSH) | 63 | |
| Overall Study | NOT COMPLETED | FSH + rhLH | 7 | |
| Overall Study | NOT COMPLETED | Follicle-stimulating Hormone (FSH) | 3 |
Source ClinicalTrials.gov
Adverse events10
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 | Ovarian Hyper Stimulation Syndrome | General disorders | FSH + rhLH | 1 | 67 | |
| other | Ovarian Hyper Stimulation Syndrome | General disorders | Follicle-stimulating Hormone (FSH) | 0 | 66 | |
| other | Urticaria post intake of food (fish) | General disorders | FSH + rhLH | 1 | 67 | |
| other | Urticaria post intake of food (fish) | General disorders | Follicle-stimulating Hormone (FSH) | 0 | 66 | |
| serious | Left ectopic pregnancy | General disorders | FSH + rhLH | 0 | 67 | |
| serious | Left ectopic pregnancy | General disorders | Follicle-stimulating Hormone (FSH) | 1 | 66 | |
| serious | Cerclage | General disorders | FSH + rhLH | 1 | 67 | |
| serious | Cerclage | General disorders | Follicle-stimulating Hormone (FSH) | 0 | 66 | |
| serious | Renal colic | General disorders | FSH + rhLH | 0 | 67 | |
| serious | Renal colic | General disorders | Follicle-stimulating Hormone (FSH) | 1 | 66 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FSH + rhLH | ||
| Total, all-cause mortality | Follicle-stimulating Hormone (FSH) | ||
| Total, other adverse events | FSH + rhLH | 2 | 67 |
| Total, other adverse events | Follicle-stimulating Hormone (FSH) | 0 | 66 |
| Total, serious adverse events | FSH + rhLH | 1 | 67 |
| Total, serious adverse events | Follicle-stimulating Hormone (FSH) | 2 | 66 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FSH + rhLH vs Follicle-stimulating Hormone (FSH): 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
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The record and each of its lists are JSON, twenty rows a page. No key.
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