Trial · NCT01075815
A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
NCT01075815, Phase 2, Terminated, Merck KGaA, Darmstadt, Germany; results first posted 2012-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age. Trials, record NCT01075815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01075815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
- NCT number
- NCT01075815
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Infertility, Ovulation Induction
- Interventions
- Recombinant human luteinizing hormone (rhLH), Recombinant follicle-stimulating hormone (rFSH)
- First posted
- 2010-02-25
- Last updated
- 2014-02-13
- Other registries' IDs
- eudract:2008-002281-55
- Results first posted
- 2012-11-20
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Implantation Rate | Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days]) | Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred. |
| Secondary | Mean 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 28 days]) | |
| Secondary | Mean Number of Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) 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. |
| Secondary | Number of Mature Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) 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 was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage. |
| Secondary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 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 two 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 and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days]) | Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation. |
| Secondary | Number of Participants With Biochemical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. |
| Secondary | Number of Participants With Clinical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. |
| Secondary | Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | |
| Secondary | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 28 days]) |
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 | Implantation Rate | Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days]) | Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. | sacs per embryo | MEAN |
| SECONDARY | Mean 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 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | follicles | MEAN |
| SECONDARY | Mean Number of Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | oocytes | MEAN |
| SECONDARY | Number of Mature Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | mature oocytes | NUMBER |
| SECONDARY | Number of Fertilized Oocytes (2 Pronuclei [PN]) | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | 2PN 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 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte. | embyros | NUMBER |
| SECONDARY | Number of Participants With Biochemical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | IU | MEAN |
| SECONDARY | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 28 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day. | picogram/milliter (pg/mL) | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Implantation Rate | rFSH + rhLH | 0.2 | Standard Deviation 0.4 | sacs per embryo | |
| Implantation Rate | rFSH | 0.2 | Standard Deviation 0.3 | sacs per embryo | |
| Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | rFSH + rhLH | 7.7 | Standard Deviation 4.9 | follicles | |
| Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | rFSH | 8.7 | Standard Deviation 4.0 | follicles | |
| Mean Number of Oocytes Retrieved | rFSH + rhLH | 5.9 | Standard Deviation 3.9 | oocytes | |
| Mean Number of Oocytes Retrieved | rFSH | 7.7 | Standard Deviation 4.0 | oocytes | |
| Number of Mature Oocytes Retrieved | rFSH + rhLH | 234 | mature oocytes | ||
| Number of Mature Oocytes Retrieved | rFSH | 271 | mature oocytes | ||
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | rFSH + rhLH | 128 | 2PN oocytes | ||
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | rFSH | 136 | 2PN oocytes |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rFSH + rhLH | 40 | |
| Overall Study | STARTED | rFSH | 35 | |
| Overall Study | COMPLETED | rFSH + rhLH | 30 | |
| Overall Study | COMPLETED | rFSH | 31 | |
| Overall Study | NOT COMPLETED | rFSH + rhLH | 10 | |
| Overall Study | NOT COMPLETED | rFSH | 4 |
Source ClinicalTrials.gov
Adverse events66
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 | Premature birth | Pregnancy, puerperium and perinatal conditions | rFSH + rhLH | 2 | 40 | |
| other | Premature birth | Pregnancy, puerperium and perinatal conditions | rFSH | 1 | 35 | |
| other | Subcutaneous haematoma | Injury, poisoning and procedural complications | rFSH + rhLH | 2 | 40 | |
| other | Subcutaneous haematoma | Injury, poisoning and procedural complications | rFSH | 2 | 35 | |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | rFSH + rhLH | 3 | 40 | |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | rFSH | 0 | 35 | |
| other | Erythema | Skin and subcutaneous tissue disorders | rFSH + rhLH | 5 | 40 | |
| other | Erythema | Skin and subcutaneous tissue disorders | rFSH | 0 | 35 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | rFSH + rhLH | 4 | 40 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | rFSH | 1 | 35 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rFSH + rhLH | ||
| Total, all-cause mortality | rFSH | ||
| Total, other adverse events | rFSH + rhLH | 17 | 40 |
| Total, other adverse events | rFSH | 8 | 35 |
| Total, serious adverse events | rFSH + rhLH | 2 | 40 |
| Total, serious adverse events | rFSH | 1 | 35 |
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 |
|---|---|
| rFSH + rhLH vs rFSH: Number of Participants With Biochemical Pregnancies | Trial comparisons |
| rFSH + rhLH vs rFSH: Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | Trial comparisons |
| rFSH + rhLH vs rFSH: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| rFSH + rhLH vs rFSH: Number of Participants With Clinical Pregnancies | Trial comparisons |
| rFSH + rhLH vs rFSH: 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/NCT01075815
GET https://conductscience.org/api/trials/v1/NCT01075815/results?page=2