Infertility,FemalePhase 2NCT04411212
G-CSF and PRP in Patients With Recurrent Implantation Failure
A Phase 2 study testing Granulocyte colony-stimulating factor and platelet-rich plasma group in people with Infertility,Female, run by Riyadh Fertility and Reproductive Health center at 1 site in Egypt.
Trial summary
The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure Read more about this study
- Who is it for?
- Ages 1 year to 35 years, women only
- Conditions the study is for
- Infertility,Female
- What is being tested?
- Granulocyte colony-stimulating factor and platelet-rich plasma group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2020to 31 Mar 2021
- Phase
- Phase 2
- 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 1 year to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred
Who cannot join
- Endometriosis
- Uterine anomalies
- Asherman syndrome
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Riyadh Fertility and Reproductive Health center
Giza
Usama M Fouda, Prof., +201095401375, umfrfouda@yahoo.com
About this study
Official title: Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure
The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure
- Conditions
- Infertility,Female
- Being tested
- Granulocyte colony-stimulating factor and platelet-rich plasma group, Control group
- Keywords
- IVF, Platelet-rich plasma, Granulocyte colony-stimulating factor, Recurrent implantation failure
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte colony-stimulating factor and platelet-rich plasma groupDrug
Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.
Control groupOther
Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.
| Study group | Role | What they receive |
|---|---|---|
| Granulocyte colony-stimulating factor and platelet-rich plasma | Active comparator | Not described Receives: Drug: Granulocyte colony-stimulating factor and platelet-rich plasma group |
| Control group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Gestational sac detected by ultrasound examination
Measured: Five weeks 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 posted2 Jun 2020
- Study start28 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Fertility and Reproductive Health center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Usama M Fouda, Prof., Study chair, Riyadh Fertility and Reproductive Health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411212
- Sponsor's protocol ID
- G-CSF and PRP in RIF
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT04411212
- Acronym / sponsor ID
- G-CSF and PRP in RIF
- Conditions
- Infertility,Female
- Keywords
- IVF, Platelet-rich plasma, Granulocyte colony-stimulating factor, Recurrent implantation failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Riyadh Fertility and Reproductive Health centerUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 2 Jun 2020 (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.
The aim of this randomized controlled trial is to determine whether granulocyte colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes in patients with recurrent implantation failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granulocyte colony-stimulating factor and platelet-rich plasma | Active comparator | Drug: Granulocyte colony-stimulating factor and platelet-rich plasma group |
| Control group | Other | Other: Control group |
Who may qualify
- Ages
- 1 year to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good quality embryos transferred
Key exclusion criteria (3 listed)
- Endometriosis
- Uterine anomalies
- Asherman syndrome
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 |
|---|---|---|
| Granulocyte colony-stimulating factor and platelet-rich plasma groupAntagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test. | Drug | Granulocyte colony-stimulating factor and platelet-rich plasma |
| Control groupAntagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus. | Other | Control group |
Primary outcome
Clinical pregnancy rate
Time frame: Five weeks after embryo transfer
Gestational sac detected by ultrasound examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Usama M Fouda, Prof. study chair
Riyadh Fertility and Reproductive Health center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Granulocyte colony-stimulating factor and platelet-rich plasma group in people with Infertility,Female, run by Riyadh Fertility and Reproductive Health center at 1 site in Egypt.
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 3 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 2 Jun 2020. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Usama M Fouda, Prof. (+0201095401375, umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Five weeks after 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 2 Jun 2020.