Infertility, FemalePhase 1/2NCT01202643
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
A Phase 1/2 study testing G-CSF and Saline in people with Infertility, Female, run by Center for Human Reproduction at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- G-CSF and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's preparing for invitro fertilization and embryo transfer with endometrial growth of less than 7 mm, unresponsive to standard treatment
Who cannot join
- Sickle Cell disease
- Renal insufficiency
- Upper respiratory infection or Pneumonia
- Chronic Neutropenia
- Known Past or present malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
New York, New York, 10021
About this study
Official title: G-CSF and Endometrial Growth, Embryo Implantation and Pregnancy Following FET or Donor ET
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.
Read the detailed description
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%.
- Conditions
- Infertility, Female
- Being tested
- G-CSF, Saline
- Keywords
- Thin Endometrium, Asherman's Syndrome, Endometrial Scarring
- Medical subject headings
- Infertility, Female, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called NEUPOGEN (Filgrastim)
One infusion of G-CSF 300 units administered by intrauterine infusion
SalineDrug
Also called Normal Saline (Salt water), 0.91% w/v of NaCl, about 300 mOsm/L
One intrauterine saline infusions of 1 cc
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation Receives: Drug: G-CSF |
| Saline | Placebo comparator | Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Thickness
Thickness of the endometrium on the day of embryo transfer
Measured: Day of embryo transfer
Secondary outcomes (1)
Implantation Rate
Number of gestational sacs per number of embryos transferred in each treatment group
Measured: 28 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Reproductive Medicine
- Responsible party
- Principal investigator, David H. Barad, Center for Human Reproduction
- Investigators
- David H Barad, MD, MS, Principal investigator, Center for Human ReproductionNorbert Gleicher, MD, Study chair, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202643
- Sponsor's protocol ID
- 09012010-01
- Status last verified
- Jul 2019
- First submitted
- 14 Sep 2010
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-CSF and Endometrial Growth, Embryo Implantation and Pregnancy Following FET or Donor ET
- ClinicalTrials.gov ID
- NCT01202643
- Acronym / sponsor ID
- 09012010-01
- Conditions
- Infertility, Female
- Keywords
- Thin Endometrium, Asherman's Syndrome, Endometrial Scarring
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Collaborators
- Foundation for Reproductive Medicine
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Posted 4 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Drug: G-CSFG-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation |
| Saline | Placebo comparator | Drug: SalineSaline administered by trans-cervical infusion one time on day of hCG trigger for ovulation |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient's preparing for invitro fertilization and embryo transfer with endometrial growth of less than 7 mm, unresponsive to standard treatment
Key exclusion criteria (5 listed)
- Sickle Cell disease
- Renal insufficiency
- Upper respiratory infection or Pneumonia
- Chronic Neutropenia
- Known Past or present malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: NEUPOGEN (Filgrastim)One infusion of G-CSF 300 units administered by intrauterine infusion | Drug | G-CSF |
| SalineAlso: Normal Saline (Salt water), 0.91% w/v of NaCl, about 300 mOsm/LOne intrauterine saline infusions of 1 cc | Drug | Saline |
Primary outcome
Endometrial Thickness
Time frame: Day of embryo transfer
Thickness of the endometrium on the day of embryo transfer
1 secondary outcome
Implantation Rate
Time frame: 28 days after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Barad, MD, MS principal investigator
Center for Human Reproduction
Norbert Gleicher, MD study chair
Center for Human Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing G-CSF and Saline in people with Infertility, Female, run by Center for Human Reproduction at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Thickness (time frame: Day of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.