Trial · NCT01121991
A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies
NCT01121991, Phase 3, Completed, EMD Serono; results first posted 2011-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies. Trials, record NCT01121991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies
- NCT number
- NCT01121991
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Infertility, Ovarian Stimulation
- Interventions
- Recombinant Human-Luteinizing Hormone (Luveris)
- First posted
- 2010-05-12
- Last updated
- 2013-08-07
- Results first posted
- 2011-03-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI) | On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration). | Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. 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. |
| Primary | Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF) | On the day of ovum pick up (Day 1 or 2 after hCG administration). | Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro. |
| Secondary | Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up | On day of ovum pick up (Day 1 or 2 after hCG administration) | Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up 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 Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Post-hCG days 15-20 and post-hCG days 35-42. | Biochemical pregnancy: A positive pregnancy test defined as hCG level \>10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat. |
| Secondary | Number of Participants With Multiple Pregnancies | Post-hCG Day 35-42. | Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals. |
| Secondary | Number of Live Births | Post-hCG days 15-20 to pregnancy follow up. | A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact. |
| Secondary | Pregnancy Loss Per Clinical Pregnancy | Post-hCG days 35-42. | Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. | From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit). | AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI) | On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration). | Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope. | Metaphase II Oocytes | MEAN |
| PRIMARY | Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF) | On the day of ovum pick up (Day 1 or 2 after hCG administration). | Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes. | oocytes | MEAN |
| SECONDARY | Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up | On day of ovum pick up (Day 1 or 2 after hCG administration) | ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up. | oocytes per aspirated follicle | MEAN |
| SECONDARY | Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Post-hCG days 15-20 and post-hCG days 35-42. | ITT population: all participants who received at least one dose of the study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Multiple Pregnancies | Post-hCG Day 35-42. | ITT population: all participants who received at least one dose of the study drug. | participants | NUMBER |
| SECONDARY | Number of Live Births | Post-hCG days 15-20 to pregnancy follow up. | ITT population: all participants who received at least one dose of the study drug. | Live births | NUMBER |
| SECONDARY | Pregnancy Loss Per Clinical Pregnancy | Post-hCG days 35-42. | Participants with confirmed clinical pregnancies. | Percentage of pregnancy loss | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. | From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit). | ITT population: all participants who received at least one dose of the study drug. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI) | Recombinant Human-Luteinizing Hormone (Luveris) | 9.5 | Standard Deviation 4.2 | Metaphase II Oocytes | |
| Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF) | Recombinant Human-Luteinizing Hormone (Luveris) | 7.5 | Standard Deviation 6.8 | oocytes | |
| Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up | Recombinant Human-Luteinizing Hormone (Luveris) | 0.9 | Standard Deviation 0.2 | oocytes per aspirated follicle | |
| Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Recombinant Human-Luteinizing Hormone (Luveris) | Participants with confirmed biochemical pregnancy | 22 | participants | |
| Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Recombinant Human-Luteinizing Hormone (Luveris) | Participants with confirmed clinical pregnancy | 14 | participants | |
| Number of Participants With Multiple Pregnancies | Recombinant Human-Luteinizing Hormone (Luveris) | 4 | participants | ||
| Number of Live Births | Recombinant Human-Luteinizing Hormone (Luveris) | 13 | Live births | ||
| Pregnancy Loss Per Clinical Pregnancy | Recombinant Human-Luteinizing Hormone (Luveris) | 7.14 | Percentage of pregnancy loss | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. | Recombinant Human-Luteinizing Hormone (Luveris) | TEAEs | 15 | Number of participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation. | Recombinant Human-Luteinizing Hormone (Luveris) | SAEs | 3 | Number of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Human-Luteinizing Hormone (Luveris) | 52 | |
| Overall Study | COMPLETED | Recombinant Human-Luteinizing Hormone (Luveris) | 46 | |
| Overall Study | NOT COMPLETED | Recombinant Human-Luteinizing Hormone (Luveris) | 6 |
Source ClinicalTrials.gov
Adverse events22
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 | Local tolerability of injections | General disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 5 | 52 | |
| other | Abdominal distension | Gastrointestinal disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 1 | 52 | |
| other | Constipation | Gastrointestinal disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 2 | 52 | |
| other | Diarrhea | Gastrointestinal disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 2 | 52 | |
| other | Flatulence | Gastrointestinal disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 1 | 52 | |
| other | Fatigue | General disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 2 | 52 | |
| other | Injection site pain | General disorders | Recombinant Human-Luteinizing Hormone (Luveris) | 1 | 52 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Recombinant Human-Luteinizing Hormone (Luveris) | 1 | 52 | |
| other | Post procedural nausea | Injury, poisoning and procedural complications | Recombinant Human-Luteinizing Hormone (Luveris) | 1 | 52 | |
| other | Procedural pain | Injury, poisoning and procedural complications | Recombinant Human-Luteinizing Hormone (Luveris) | 2 | 52 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Human-Luteinizing Hormone (Luveris) | ||
| Total, other adverse events | Recombinant Human-Luteinizing Hormone (Luveris) | 15 | 52 |
| Total, serious adverse events | Recombinant Human-Luteinizing Hormone (Luveris) | 3 | 52 |
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 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/NCT01121991
GET https://conductscience.org/api/trials/v1/NCT01121991/events?page=2