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| Name | Class |
|---|---|
| Foundation for Reproductive Medicine | OTHER |
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This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.
Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).
Design: Double blinded crossover randomized controlled clinical trial
Setting: Academically affiliated private infertility centers
Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.
Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.
Main Outcome Measures: Implantation rate(IR) and pregnancy rates.
Second Outcome Measures: Live birth rates and miscarriage rates.
Statistical and Power considerations: Analysis will be by regression with IR as dependent and treatment as independent. Results will be adjusted by age and indices of ovarian reserve, such as antiMulerian Hormone (AMH). Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF then Saline | Experimental | G-CSF (Granulocyte colony stimulating factor) |
|
| Saline then G-CSF | Placebo Comparator | Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug | One infusion of G-CSF 300 units administered by intrauterine infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Embryo Implantation and Clinical Pregnancy Rates | Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred Clinical pregnancy: Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer | 26 to 30 days after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rates | Live birth rates among normal infertile couples undergoing IVF | Within nine months of embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Barad, MD, MS | Center for Human Reproduction | Principal Investigator |
| Norbert Gleicher, MD | Center for Human Reproduction | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Human Reproduction | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24424357 | Result | Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11. |
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The principal reasons for refusal to participate were ''lack of interest'' and technical difficulties in presenting in timely fashion for the treatment to the center. Women with renal disease, sickle cell disease, or a history of malignancy were considered ineligible. No consenting patient was excluded from participation for medical reasons.
All patients presenting for embryos transfer between October 3, 2010, and January 1, 2013, were offered participation in the trial. A total of 419 eligible patients were offered participation: Only 129 patients consented to participate in this study,(12 addtional patient participated in the thin endometrium study) and 278 declined
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| ID | Title | Description |
|---|---|---|
| FG000 | G-CSF Then Saline | G-CSF (Granulocyte colony stimulating factor) G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation |
| FG001 | Saline Then G-CSF | Normal Saline Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 |
| |||||||||||||
| CrossoverCycle |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | G-CSF Then Saline | G-CSF (Granulocyte colony stimulating factor) G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Normal Saline Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Embryo Implantation and Clinical Pregnancy Rates | Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred Clinical pregnancy: Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer | Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05. | Posted | Number | Gestational sacs | 26 to 30 days after embryo transfer | Embryos Transferred | Participants |
|
1 year
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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 | G-CSF | G-CSF (Granulocyte colony stimulating factor) G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation |
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The study results are applicable only to women undergoing routine IVF. Most of the women in this trial had normal endometrial thickness at randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Barad | Center for Human Reproduction | 212 994-4400 | dbarad@theCHR.com |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Saline | Drug | intrauterine saline infusion 1 cc |
|
|
| NOT COMPLETED |
|
| Saline Then G-CSF |
Normal Saline Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF (Granulocyte colony stimulating factor) G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| AntiMulerian Hormone (AMH) | Mean | Standard Deviation | ng/mL |
|
| OG001 |
| Saline |
Normal Saline Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation |
|
|
|
| Secondary | Live Birth Rates | Live birth rates among normal infertile couples undergoing IVF | Posted | Number | Live Birth | Within nine months of embryo transfer |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Saline | Normal Saline Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation | 0 | 80 | 0 | 80 |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |