Infertility, FemalePhase 1/2NCT01202656

Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 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: 129 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Jun 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 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women already enrolled in an IVF cycle at one of the participating institutions

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

Other trials in United States

About this study

Official title: G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)

Read the detailed description

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.

Conditions: Infertility, Female
Being tested: G-CSF, Saline
Keywords: Fertility Agents, Female, In vitro fertilization
Medical subject headings: Infertility, Female

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, 0.91% w/v of NaCl, about 300 mOsm/L
intrauterine saline infusion 1 cc

Study groups in NCT01202656
Study group	Role	What they receive
G-CSF then Saline	Experimental	G-CSF (Granulocyte colony stimulating factor) Receives: Drug: G-CSF; Drug: Saline
Saline then G-CSF	Placebo comparator	Normal Saline Receives: Drug: G-CSF; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 26 to 30 days after embryo transfer

Secondary outcomes (1)

Live Birth Rates
Live birth rates among normal infertile couples undergoing IVF
Measured: Within nine months of embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jun 2013

First posted16 Sep 2010 (estimated)
Study startSep 2010
Primary completionDec 2012
Study completionJun 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01202656
Sponsor's protocol ID: 09012010-02
Status last verified: Nov 2014
First submitted: 14 Sep 2010
Last updated: 2 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24424357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)
ClinicalTrials.gov ID: NCT01202656
Acronym / sponsor ID: 09012010-02
Conditions: Infertility, Female
Keywords: Fertility Agents, Female, In vitro fertilization
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Center for Human ReproductionUniversity, hospital or other
Collaborators: Foundation for Reproductive Medicine
Study start: Sep 2010
Primary completion: Dec 2012 (actual)
Study completion: Jun 2013 (actual)
First posted: 16 Sep 2010 (estimated)
Results: Posted 2 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Main Outcome Measures: Implantation rate(IR) and pregnancy rates.

Second Outcome Measures: Live birth rates and miscarriage rates.

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 then Saline	Experimental	Drug: G-CSF, Drug: SalineG-CSF (Granulocyte colony stimulating factor)
Saline then G-CSF	Placebo comparator	Drug: G-CSF, Drug: SalineNormal Saline

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Women already enrolled in an IVF cycle at one of the participating institutions

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 then Saline, Saline then G-CSF
SalineAlso: Normal Saline, 0.91% w/v of NaCl, about 300 mOsm/Lintrauterine saline infusion 1 cc	Drug	G-CSF then Saline, Saline then G-CSF

Primary outcome

Embryo Implantation and Clinical Pregnancy Rates
Time frame: 26 to 30 days after embryo transfer
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

1 secondary outcome

Live Birth Rates
Time frame: Within nine months of embryo transfer

Results and safety

Results posted to the registry on 2 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
G-CSF Then Saline	67	67
Saline Then G-CSF	62	62

Primary outcome: Embryo Implantation and Clinical Pregnancy Rates

Time frame: 26 to 30 days after embryo transfer. Number. Unit: Gestational sacs

Measure	G-CSF n = 81	Saline n = 80
Value	32	33

G-CSF vs Saline: p = 0.72, Cochran-Mantel-Haenszel

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
G-CSF	0 of 81 (0%)	0 of 81 (0%)	Not reported
Saline	0 of 80 (0%)	0 of 80 (0%)	Not reported

Limitations and caveats (from the sponsor): The study results are applicable only to women undergoing routine IVF. Most of the women in this trial had normal endometrial thickness at randomization.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24424357Barad 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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Not yet recruitingObservational study
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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: finished, as of the sponsor's last update on 2 Dec 2014. 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 2 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?

Embryo Implantation and Clinical Pregnancy Rates (time frame: 26 to 30 days after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01202656, which also lists 1 linked publication.

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 2 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.