A Phase 1/2 interventional study of G-CSF and Saline in Infertility, Female, sponsored by Center for Human Reproduction. Terminated at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-26.
Sponsored by Center for Human Reproduction · Phase 1/2, Interventional, and Treatment
The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in women who have failed reaching minimal endometrial thickness by standard treatments, to assess how many reach embryo transfer and what implantation and pregnancy rates are in comparison to control patients. The study will be conducted in women undergoing transfer of previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.
Objective: To investigate the effect of treatment with CSF : A placebo controlled double blinded crossover study.
Design: Crossover Randomized Control Trial
Setting: Academically affiliated private infertility centers
Subjects: Female IVF patients of all ages who are willing to be randomized to treatment and, in either IVF treatment, frozen embryo cycles (FET) or donor IVF cycles (D-IVF), 5 days before ET, have inadequate endometrial thickness.
Interventions: Subjects receive transvaginally, utilizing an insemination catheter, 2 slow intrauterine lavages with CSF-1 (Neupogen or generic, 300ug in 1 ml) 5 and 3 days, respectively, before embryo transfer and controls receive 1 ml of saline instead. Patients who do not become pregnant will after one month washout times continue treatment in the opposite study arm if they so choose and if they have remaining embryos.
Main Outcome Measures: Number of patients reaching embryo transfer with adequate endometrial thickness of at least 7mm.
Second Outcome Measures: Implantation and pregnancy rates..
Statistical and Power considerations: This is a Randomized Controlled Trial (RCT) with two study arms and panned crossover. Patients will be randomly assigned to Study group A or B according to a computer generated randomization table with 50:50 distributions. The study will test the null hypothesis that there is no difference in the transfer rates between the two groups. Transfer is only possible if the endometrial thickness reaches 7 mm or more. Order of treatment ab v ba will be added to the models as a separate factor and each phase will be analyzed as separate treatment strata.
The investigators are planning a study of independent cases and controls with 1 control per case. Prior data indicate that the transfer rate among controls is \< 1%. If the true transfer rate for experimental subjects is 25%, the investigators will need to study 38 experimental subjects and 38 control subjects to be able to reject the null hypothesis that the transfer rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use a continuity-corrected chi-squared statistic or Fisher's exact test to evaluate this null hypothesis.
There will be a planned interim analysis after 20 participants have completed the trial and if significant effects are observed the trial may be terminated at that time. The power to detect a difference in this interim analysis is only 42.6%.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 12 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Center for Human Reproduction is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
Drug: G-CSF
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
Drug: Saline
One infusion of G-CSF 300 units administered by intrauterine infusion
Also known as: NEUPOGEN (Filgrastim)
One intrauterine saline infusions of 1 cc
Also known as: Normal Saline (Salt water), 0.91% w/v of NaCl, about 300 mOsm/L
Endometrial Thickness
Thickness of the endometrium on the day of embryo transfer
Time frame: Day of embryo transfer
Implantation Rate
Number of gestational sacs per number of embryos transferred in each treatment group
Time frame: 28 days after embryo transfer
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 12 patients consented to participate in this study,(129 addtional patient participated in the NCT01202656 study) and 278 declined.
| Milestone | G-CSF Then Saline | Saline Then G-CSF |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
| Milestone | G-CSF Then Saline | Saline Then G-CSF |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
Thickness of the endometrium on the day of embryo transfer
| mm | G-CSF | Saline |
|---|---|---|
| Endometrial Thickness | 11.3 ± 3.1 | 7.8 ± 0.8 |
Number of gestational sacs per number of embryos transferred in each treatment group
| Gestational sacs | G-CSF | Saline |
|---|---|---|
| Implantation Rate | 1 | 2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| G-CSF | — | 0/8 (0%) | 0/8 (0%) |
| Saline | — | 0/7 (0%) | 0/7 (0%) |
The transfer rate among controls should be \< 1%. If the true transfer rate for experimental subjects is 25%, we will need to study 38 experimental subjects and 38 control subjects to be able to reject the null hypothesis that the transfer rates for experimental and control subjects are equal with probability (power) 0.8.
| Age, Categorical(Participants) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 12 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| Mean | 39.79 ± 5.13 | 39.38 ± 6.03 | 39.59 ± 5.56 |
| Sex: Female, Male(Participants) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 5 | 6 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| FSH(mIU/mL) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| Mean | 8.64 ± 3.92 | 8.27 ± 4.01 | 8.46 ± 3.95 |
| Endometrial Thickness(mm) | G-CSF Then Saline | Saline Then G-CSF | Total |
|---|---|---|---|
| Mean | 5.6 ± 0.22 | 6.2 ± 0.69 | 5.8 ± 0.46 |
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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