Trial · NCT01079949
A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age
NCT01079949, Phase 2, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2013-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age. Trials, record NCT01079949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01079949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age
- NCT number
- NCT01079949
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility, Ovulation Induction
- Interventions
- r-hLH + r-hFSH, r-hFSH, Recombinant Human Choriogonadotropin (r-hCG), GnRH antagonist
- First posted
- 2010-03-03
- Last updated
- 2014-02-27
- Other registries' IDs
- eudract:2006-005268-19
- Results first posted
- 2013-02-20
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. |
| Primary | Number of Mature Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. 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. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic. |
| Primary | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Primary | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Primary | Number of Participants With Adverse Events (AEs) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. |
| Secondary | Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | |
| Secondary | Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | Endometrial thickness measurement was performed on the day of r-hCG administration. |
| Secondary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 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 | Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) | Oocytes were fertilized using 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. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN. |
| Secondary | Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 | Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | oocytes | MEAN |
| PRIMARY | Number of Mature Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | mature oocytes | NUMBER |
| PRIMARY | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | cycles | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | follicles | MEAN |
| SECONDARY | Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | mm | MEAN |
| SECONDARY | Number of Fertilized Oocytes (2 Pronuclei [PN]) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | 2PN oocytes | NUMBER |
| SECONDARY | Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | oocytes | NUMBER |
| SECONDARY | Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development. | embryos | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group56
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-hFSH + r-hLH | 10 | Standard Deviation 3.8 | oocytes | |
| Number of Oocytes Retrieved | r-hFSH | 10 | Standard Deviation 5.2 | oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH + r-hLH | Geminal vesicle (GV) | 60 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH | Geminal vesicle (GV) | 37 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH + r-hLH | Meta-I | 44 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH | Meta-I | 26 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH + r-hLH | Meta-II | 275 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH | Meta-II | 292 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH + r-hLH | Atresic | 10 | mature oocytes | |
| Number of Mature Oocytes Retrieved | r-hFSH | Atresic | 4 | mature oocytes |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 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-hFSH + r-hLH | 46 | |
| Overall Study | STARTED | r-hFSH | 47 | |
| Overall Study | COMPLETED | r-hFSH + r-hLH | 31 | |
| Overall Study | COMPLETED | r-hFSH | 34 | |
| Overall Study | NOT COMPLETED | r-hFSH + r-hLH | 15 | |
| Overall Study | NOT COMPLETED | r-hFSH | 13 |
Source ClinicalTrials.gov
Adverse events4
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 | Vomiting | Gastrointestinal disorders | r-hFSH + r-hLH | 1 | 45 | |
| other | Vomiting | Gastrointestinal disorders | r-hFSH | 0 | 47 | |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | r-hFSH + r-hLH | 2 | 45 | |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | r-hFSH | 0 | 47 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | r-hFSH + r-hLH | ||
| Total, all-cause mortality | r-hFSH | ||
| Total, other adverse events | r-hFSH + r-hLH | 1 | 45 |
| Total, other adverse events | r-hFSH | 0 | 47 |
| Total, serious adverse events | r-hFSH + r-hLH | 2 | 45 |
| Total, serious adverse events | r-hFSH | 0 | 47 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| r-hFSH + r-hLH vs r-hFSH: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| r-hFSH + r-hLH vs r-hFSH: Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response | Trial comparisons |
| r-hFSH + r-hLH vs r-hFSH: Number of Participants With Clinical Pregnancies | Trial comparisons |
| r-hFSH + r-hLH vs r-hFSH: Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | Trial comparisons |
| r-hFSH + r-hLH vs r-hFSH: 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/NCT01079949
GET https://conductscience.org/api/trials/v1/NCT01079949/results?page=2