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Slow enrollment resulted in withdraw of funding
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.
Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms:
I. The partial suppression of FSH will allow for further recruitment of early antral follicles.
II. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Start | Experimental | Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. |
|
| Conventional Start | Active Comparator | Ovarian stimulation with standard antagonist protocols (no delay). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganirelix acetate | Drug | Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Proportions | Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval. | 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization |
| Number of Oocytes Retrieved | The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted | up to 1 hour after oocytes retrieved |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo Quality | Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells. | One hour on day 2 or 3 (following IVF procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Rosen, MD | UCSF Center for Reproductive Health and Fertility Preservation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Center for Reproductive Health | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21300334 | Background | Blockeel C, Riva A, De Vos M, Haentjens P, Devroey P. Administration of a gonadotropin-releasing hormone antagonist during the 3 days before the initiation of the in vitro fertilization/intracytoplasmic sperm injection treatment cycle: impact on ovarian stimulation. A pilot study. Fertil Steril. 2011 Apr;95(5):1714-9.e1-2. doi: 10.1016/j.fertnstert.2011.01.028. |
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With a goal of enrolling a total of 114 subjects, 330 potential candidates were screened for eligibility. 300 candidates were either not eligible or declined participation. 30 subjects were found eligible to participate and enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed Start | Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
| FG001 | Conventional Start | Ovarian stimulation with standard antagonist protocols (no delay). Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed Start | Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
| BG001 | Conventional Start |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Female patients ages 18 years and older who were seeking IVF treatment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fertilization Proportions | Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval. | The study was terminated early and no data were collected for this outcome measure | Posted | 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Start | Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Rosen, MD | University of California, San Francisco | 415-353-7475 |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C061018 | ganirelix |
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| Pregnancy Rates | Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value > 5 mIU/ml ) observed over the time frame. | 2 to 3 weeks following embryo transfer |
| Stages of Oocyte Nuclear Maturation | Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II) | average of 1 to 2 hours on the Day of Retrieval |
| Number of Mature Follicles | Maturation of follicles will be assessed by measuring the size of follicles (mature > 13mm) prior to (or at the time of) oocytes retrieval. | up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes) |
| Oocyte Recovery Rate | The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation. | up to 1 hours after oocyte retrieval |
| Withdrawal by Subject |
|
| Study terminated early by sponsor and was unable to collect data |
|
Ovarian stimulation with standard antagonist protocols (no delay). Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Conventional Start |
Ovarian stimulation with standard antagonist protocols (no delay). Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist |
|
| Primary | Number of Oocytes Retrieved | The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted | The study was terminated early and no data were collected for this outcome measure | Posted | up to 1 hour after oocytes retrieved |
|
|
| Secondary | Embryo Quality | Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells. | The study was terminated early and no data were collected for this outcome measure | Posted | One hour on day 2 or 3 (following IVF procedure) |
|
|
| Secondary | Pregnancy Rates | Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value > 5 mIU/ml ) observed over the time frame. | The study was terminated early and no data were collected for this outcome measure | Posted | 2 to 3 weeks following embryo transfer |
|
|
| Secondary | Stages of Oocyte Nuclear Maturation | Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II) | The study was terminated early and no data were collected for this outcome measure | Posted | average of 1 to 2 hours on the Day of Retrieval |
|
|
| Secondary | Number of Mature Follicles | Maturation of follicles will be assessed by measuring the size of follicles (mature > 13mm) prior to (or at the time of) oocytes retrieval. | The study was terminated early and no data were collected for this outcome measure | Posted | up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes) |
|
|
| Secondary | Oocyte Recovery Rate | The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation. | The study was terminated early and no data were collected for this outcome measure | Posted | up to 1 hours after oocyte retrieval |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Conventional Start | Ovarian stimulation with standard antagonist protocols (no delay). Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist | 0 | 15 | 0 | 15 | 0 | 15 |
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