Women InfertilityPhase 2/3NCT03163862
G-CSF Administration in IVF in a Preferable Preceptive Endometrium Score
A Phase 2/3 study testing Endometrial scratch, G-CSF administration and Saline Solution in people with Women Infertility, run by Istishari Arab Hospital.
Trial summary
This is a controlled preminary trial intended to increase the implantation rate of IVF cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1, as a determinant for intervention by G-CSF… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Women Infertility
- What is being tested?
- Endometrial scratch, G-CSF administration and Saline Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Jan 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ALL Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.
Who cannot join
- • contraindications for G-CSF treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)
About this study
Official title: Granulocyte Stimulating Factor (G-CSF) to Increase the Rate of Implantation Success in IVF Patients in Preferable Preceptive Endometrium Scroe
This is a controlled preminary trial intended to increase the implantation rate of IVF cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1, as a determinant for intervention by G-CSF, according to a score that can be done on a small sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine and subcutaneously.
Read the detailed description
Placebo: CONTROL patients treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Drug\& scratching CONTROL saline infusion every day from the day of embryo transfer through the day of beta HCG test Other Name: SALINE INFUSION Experimental: G-CSF group patients treated with G-CSF if the biopsy adhesive score 1-3 only
- Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before.
- Drug \&scratching : G-CSF group
1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, 2- subcutaneous 300 micrograms G-CSF on the day of embryo transfer Comparative group patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only
Scratching only :
Patients undergoing scratching on day 21-24 of prior IVF cycle/ and on day 5 of IVF cycle with biopsy score of 4.
- Conditions
- Women Infertility
- Being tested
- Endometrial scratch, G-CSF administration, Saline Solution
- Keywords
- IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial scratchProcedure or surgery
the intervention group, endometrial biopsy will be performed with a pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France). The pipelle was introduced gently through the cervix up to the uterine fundus. the examiner applied regular back-and-forth movements (2-4 cm) during a period of 30 s. The obtained specimens will be sent for histology evaluation.
G-CSF administrationDrug
1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, subcutaneous 300 micrograms G-CSF on the day of embryo transfer
Saline SolutionDrug
saline infusion every day from the day of embryo transfer through the day of beta HCG test
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Receives: Drug: Saline Solution |
| G-CSF group | Experimental | Patients treated with G-CSF if the biopsy adhesive score 1-3 only, by Endometrial scratching and adhesive factor scoring on day 21-24 cycle prior to IVF//or day 3 of IVF cycle not planned before.
The dose of G-CSF is 300 µg by trans cervical intrauterine route administered at the oocyte retrieval day, Ans subcutaneous 300µg G-CSF on the day of embryo transfer Receives: Procedure: Endometrial scratch; Drug: G-CSF administration |
| Comparative group | Sham comparator | patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only Receives: Procedure: Endometrial scratch |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy per women randomized
pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy
Measured: 4 weeks
Secondary outcomes (1)
setting a score of precepative endometrium
Evaluation of the endometrial biopsy and setting a receptive score/ adhesive factors of the endometrium
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women InfertilityStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istishari Arab Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Salem Abu Khyzaran, Nizam Najeeb
- Responsible party
- Principal investigator, Areej Khatib, Istishari Arab Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163862
- Sponsor's protocol ID
- 0001
- Status last verified
- Jun 2017
- First submitted
- 21 May 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte Stimulating Factor (G-CSF) to Increase the Rate of Implantation Success in IVF Patients in Preferable Preceptive Endometrium Scroe
- ClinicalTrials.gov ID
- NCT03163862
- Acronym / sponsor ID
- 0001
- Conditions
- Women Infertility
- Keywords
- IVF
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istishari Arab HospitalUniversity, hospital or other
- Collaborators
- Salem Abu Khyzaran, Nizam Najeeb
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a controlled preminary trial intended to increase the implantation rate of IVF cycles, by using more than one known procedure, endometrial scratching, evaluating the status of the adhesive factors as αVβ3 integrin, L-selectin ligand MECA-79, E-cadherin and ICAM-1, as a determinant for intervention by G-CSF, according to a score that can be done on a small sample obtained during scratching, then give G-CSF for the scores less than 4 intrauterine and subcutaneously.
Detailed description
Placebo: CONTROL patients treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test Drug\& scratching CONTROL saline infusion every day from the day of embryo transfer through the day of beta HCG test Other Name: SALINE INFUSION Experimental: G-CSF group patients treated with G-CSF if the biopsy adhesive score 1-3 only
- Endometrial scratching and adhesive factor score, day 21-24 cycle prior to IVF//0rv day 3 of IVF cycle not planned before.
- Drug \&scratching : G-CSF group
1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, 2- subcutaneous 300 micrograms G-CSF on the day of embryo transfer Comparative group patients not treated with G-CSF after scratching if the biopsy adhesive score 4 only
Scratching only :
Patients undergoing scratching on day 21-24 of prior IVF cycle/ and on day 5 of IVF cycle with biopsy score of 4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Saline SolutionPatients treated with infusion of PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test |
| G-CSF group | Experimental | Procedure: Endometrial scratch, Drug: G-CSF administrationPatients treated with G-CSF if the biopsy adhesive score 1-3 only, by Endometrial scratching and adhesive factor scoring on day 21-24 cycle prior to IVF//or day 3 of IVF cycle not planned before. The dose of G-CSF is 300 µg by trans cervical intrauterine route administered at the oocyte retrieval day, Ans subcutaneous 300µg G-CSF on the day of embryo transfer |
| Comparative group | Sham comparator | Procedure: Endometrial scratchpatients not treated with G-CSF after scratching if the biopsy adhesive score 4 only |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ALL Women aged < 40 years who would be submitted to oocyte retrieval and embryo transfer IN IVF cycle.
Key exclusion criteria (1 listed)
- • contraindications for G-CSF treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)
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 |
|---|---|---|
| Endometrial scratchthe intervention group, endometrial biopsy will be performed with a pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France). The pipelle was introduced gently through the cervix up to the uterine fundus. the examiner applied regular back-and-forth movements (2-4 cm) during a period of 30 s. The obtained specimens will be sent for histology evaluation. | Procedure or surgery | Comparative group, G-CSF group |
| G-CSF administration1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, subcutaneous 300 micrograms G-CSF on the day of embryo transfer | Drug | G-CSF group |
| Saline Solutionsaline infusion every day from the day of embryo transfer through the day of beta HCG test | Drug | Placebo |
Primary outcome
clinical pregnancy per women randomized
Time frame: 4 weeks
pregnancy diagnosed by ultrasonographic visualisation of one or more gestational sacs, including ectopic pregnancy
1 secondary outcome
setting a score of precepative endometrium
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Endometrial scratch, G-CSF administration and Saline Solution in people with Women Infertility, run by Istishari Arab Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
clinical pregnancy per women randomized (time frame: 4 weeks). 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 19 Jun 2017.