Infertility Due to NonimplantationPhase 2NCT04240860
Autologous Intrauterine Platelet-Rich Plasma Instillation And Endometrial Scratching for Thinned Endometrium
A Phase 2 study testing platlet rich plasma and endometrial scratch in people with Infertility Due to Nonimplantation, run by Suez Canal University.
Trial summary
aim of that study is to compare the effect between autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching for thinned endometrium. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Due to Nonimplantation
- What is being tested?
- platlet rich plasma and endometrial scratch
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2020to 1 Aug 2020
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure Age between 18 and 38years
Who cannot join
- Age < 18 and > 46 years Pregnancy Bleeding diathesis Previous uterine surgery (miomectomy, cesarean section, etc...) Platelet count < 105/μL Hemoglobin < 10 g/dL Presence of a tumor in the wound bed or metastatic disease Current diagnosis of cancer Other concomitant active infections Other factors of infertility ( PCO, tubal block, congenital anomalies, genetic malformation, male infertility)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Clinical Trial Between Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching for Thinned Endometrium
aim of that study is to compare the effect between autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching for thinned endometrium.
Read the detailed description
Embryo implantation is a very delicate and well-orchestrated process that is governed by the interaction between several maternal and embryonic factors, ultimately resulting in adherence of the blastocyst to the endometrium. For a short period of time during the normal menstrual cycle, the endometrium represents the fertile "soil" for the implanting embryo. The human endometrium undergoes complex changes, in response to circulating estrogen and progesterone, which culminate at the mid-luteal phase of the menstrual cycle when it becomes suitable to host the blastocyst.
In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate endometrial growth is performed using grey-scale ultrasound. The minimal endometrial thickness required for embryo transfer is now considered about 7 mm at the end of natural or medically induced follicular phase Local injury to the endometrium has been proposed as a means to improve implantation in women with RIF. Initial non-randomized studies showed a doubling of implantation rates after 2-4 endometrial injuries performed at different time points of the menstrual cycle in women with previous implantation failure . Following that, a number of randomized trials focusing on women with RIF have been conducted. The majority of the trials have demonstrated significant improvements in implantation rates, clinical pregnancy rates and/or live birth rates following endometrial injury performed in the preceding cycle Platelet rich plasma (PRP) represents a relatively new approach in regenerative medicine. It is obtained from patient's own blood and contains different growth factors and other biomolecules necessary for wound healing. Platelet rich plasma (PRP) therapy has accumulated considerable attention over the two last decades, mainly due to its potential ability in regenerative medicine. Platelets as a main components of the PRP, contain more than 1100 different proteins, with numerous post-translational modifications, resulting in over 1500 protein-based bioactive factors These factors include immune system messengers, growth factors, enzymes and their inhibitors and factors which can participate in tissue repair and wound healing. Another important characteristic of PRP is that represents an autologous product, which is prepared from the patient's own blood. Therefore, the use of autologous PRP eliminates any concerns about the risk of crossed contamination, disease transmission or immune reactions
- Conditions
- Infertility Due to Nonimplantation
- Being tested
- platlet rich plasma, endometrial scratch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platlet rich plasmaBiological
Drug: PRP PRP subendometrial infusion
Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle
endometrial scratchProcedure or surgery
Three Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma preparation | Experimental | * About 15 ml of autologous blood from the patient was collected slowly in 20 ml syringe containing 1.5 ml anticoagulant citrate dextrose solution A (ACDA) under complete aseptic precautions.
2- Blood was mixed by swinging the syringe slowly. 3- By using 18G needle, the gathered blood was transfused into tube maintaining a slope of 45°.
4- The centrifugation step was then done by using non digital angle type centrifuge :the tube was put with water tube on the opposite side to achieve centrifuge balance.
5- The centrifugation occurred in one step by power 3600 RPM for 6 minutes. 6- The buffy coat was elevated up to the buffy coat line (Figure 1). 7- the buffy coat (2-3 ml PRP) was extracted from slim neck by tornado technique so that sunk platelets can be floated and drawn easily.
8- the remaining platelet poor plasma(PPP) was drawn using 5 cc syringe. then inserted by ovum pick up needle into subendometrium Receives: Biological: platlet rich plasma |
| endometrial scratch | Active comparator | using scissor of hysteroscopr 3 snips was done in the fundus Receives: Procedure: endometrial scratch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
Endometrial thickness > 7 mm measured by means of transvaginal ultrasound
Measured: 24-48h after intervention
Secondary outcomes (1)
Positive pregnancy test rate
Positive pregnancy test rate
Measured: Approximately 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start23 Jan 2020 (estimated)
- Primary completion10 Mar 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infertility Due to NonimplantationStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohsen Ahmed Mostafa Abo elnasr, Suez Canal University
- Investigators
- Mohamed M Farrag, Ph.D, Study chair, professorElham H Madney, Ph.D, Study director, assisted professorRasha E Khamiss, PH.D, Principal investigator, lecturar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240860
- Sponsor's protocol ID
- prp thinned endometrium
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
PubMed 28333034Molina A, Sanchez J, Sanchez W, Vielma V. Platelet-rich plasma as an adjuvant in the endometrial preparation of patients with refractory endometrium. JBRA Assist Reprod. 2018 Mar 1;22(1):42-48. doi: 10.5935/1518-0557.20180009.
PubMed 29303234Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
PubMed 29142450Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.
PubMed 23754314Shokeir T, Ebrahim M, El-Mogy H. Hysteroscopic-guided local endometrial injury does not improve natural cycle pregnancy rate in women with unexplained infertility: Randomized controlled trial. J Obstet Gynaecol Res. 2016 Nov;42(11):1553-1557. doi: 10.1111/jog.13077. Epub 2016 Jul 1.
PubMed 27363928
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Between Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching for Thinned Endometrium
- ClinicalTrials.gov ID
- NCT04240860
- Acronym / sponsor ID
- prp thinned endometrium
- Conditions
- Infertility Due to Nonimplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (estimated)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 27 Jan 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.
aim of that study is to compare the effect between autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching for thinned endometrium.
Detailed description
Embryo implantation is a very delicate and well-orchestrated process that is governed by the interaction between several maternal and embryonic factors, ultimately resulting in adherence of the blastocyst to the endometrium. For a short period of time during the normal menstrual cycle, the endometrium represents the fertile "soil" for the implanting embryo. The human endometrium undergoes complex changes, in response to circulating estrogen and progesterone, which culminate at the mid-luteal phase of the menstrual cycle when it becomes suitable to host the blastocyst.
In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate endometrial growth is performed using grey-scale ultrasound. The minimal endometrial thickness required for embryo transfer is now considered about 7 mm at the end of natural or medically induced follicular phase Local injury to the endometrium has been proposed as a means to improve implantation in women with RIF. Initial non-randomized studies showed a doubling of implantation rates after 2-4 endometrial injuries performed at different time points of the menstrual cycle in women with previous implantation failure . Following that, a number of randomized trials focusing on women with RIF have been conducted. The majority of the trials have demonstrated significant improvements in implantation rates, clinical pregnancy rates and/or live birth rates following endometrial injury performed in the preceding cycle Platelet rich plasma (PRP) represents a relatively new approach in regenerative medicine. It is obtained from patient's own blood and contains different growth factors and other biomolecules necessary for wound healing. Platelet rich plasma (PRP) therapy has accumulated considerable attention over the two last decades, mainly due to its potential ability in regenerative medicine. Platelets as a main components of the PRP, contain more than 1100 different proteins, with numerous post-translational modifications, resulting in over 1500 protein-based bioactive factors These factors include immune system messengers, growth factors, enzymes and their inhibitors and factors which can participate in tissue repair and wound healing. Another important characteristic of PRP is that represents an autologous product, which is prepared from the patient's own blood. Therefore, the use of autologous PRP eliminates any concerns about the risk of crossed contamination, disease transmission or immune reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma preparation | Experimental | Biological: platlet rich plasma* About 15 ml of autologous blood from the patient was collected slowly in 20 ml syringe containing 1.5 ml anticoagulant citrate dextrose solution A (ACDA) under complete aseptic precautions. 2- Blood was mixed by swinging the syringe slowly. 3- By using 18G needle, the gathered blood was transfused into tube maintaining a slope of 45°. 4- The centrifugation step was then done by using non digital angle type centrifuge :the tube was put with water tube on the opposite side to achieve centrifuge balance. 5- The centrifugation occurred in one step by power 3600 RPM for 6 minutes. 6- The buffy coat was elevated up to the buffy coat line (Figure 1). 7- the buffy coat (2-3 ml PRP) was extracted from slim neck by tornado technique so that sunk platelets can be floated and drawn easily. 8- the remaining platelet poor plasma(PPP) was drawn using 5 cc syringe. then inserted by ovum pick up needle into subendometrium |
| endometrial scratch | Active comparator | Procedure: endometrial scratchusing scissor of hysteroscopr 3 snips was done in the fundus |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure Age between 18 and 38years
Key exclusion criteria (1 listed)
- Age < 18 and > 46 years Pregnancy Bleeding diathesis Previous uterine surgery (miomectomy, cesarean section, etc...) Platelet count < 105/μL Hemoglobin < 10 g/dL Presence of a tumor in the wound bed or metastatic disease Current diagnosis of cancer Other concomitant active infections Other factors of infertility ( PCO, tubal block, congenital anomalies, genetic malformation, male infertility)
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 |
|---|---|---|
| platlet rich plasmaDrug: PRP PRP subendometrial infusion Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle | Biological | platelet rich plasma preparation |
| endometrial scratchThree Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle | Procedure or surgery | endometrial scratch |
Primary outcome
Endometrial thickness
Time frame: 24-48h after intervention
Endometrial thickness > 7 mm measured by means of transvaginal ultrasound
1 secondary outcome
Positive pregnancy test rate
Time frame: Approximately 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 28333034Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
- Background: PubMed 29303234Molina A, Sanchez J, Sanchez W, Vielma V. Platelet-rich plasma as an adjuvant in the endometrial preparation of patients with refractory endometrium. JBRA Assist Reprod. 2018 Mar 1;22(1):42-48. doi: 10.5935/1518-0557.20180009.
- Background: PubMed 29142450Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
- Background: PubMed 23754314Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.
- Background: PubMed 27363928Shokeir T, Ebrahim M, El-Mogy H. Hysteroscopic-guided local endometrial injury does not improve natural cycle pregnancy rate in women with unexplained infertility: Randomized controlled trial. J Obstet Gynaecol Res. 2016 Nov;42(11):1553-1557. doi: 10.1111/jog.13077. Epub 2016 Jul 1.
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.
Mohamed M Farrag, Ph.D study chair
professor
Elham H Madney, Ph.D study director
assisted professor
Rasha E Khamiss, PH.D principal investigator
lecturar
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing platlet rich plasma and endometrial scratch in people with Infertility Due to Nonimplantation, run by Suez Canal University.
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 27 Jan 2020. 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. 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 Mohamed M Aboelnasr, M.B.B.Ch. (201009988713, Aboelnasr91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: 24-48h after intervention). 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 NCT04240860, which also lists 5 linked publications.
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 27 Jan 2020.