Frozen Embryo TransferNCT04247204
Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles
A study testing Platelet-rich plasma intrauterine infusion in people with Frozen Embryo Transfer, run by Hatem AbuHashim.
Trial summary
A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Frozen Embryo Transfer
- What is being tested?
- Platelet-rich plasma intrauterine infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2020to 5 Oct 2020
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.
- Age between 20-35 years.
- Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle
Who cannot join
- Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
- Women with known hematological or immunological disorders
- Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.
- Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.
- Women who refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 3D Power Doppler Ultrasound Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen-thawed Embryo Transfer Cycles: a Pilot Study.
A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. A thin endometrium defined by an endometrial thickness ≤7mm was reported as a poor factor associated with significantly lower implantation and pregnancy rates as well as a higher risk of miscarriage.
Nowadays, platelet-rich plasma (PRP) intrauterine infusion is a promising approach for the treatment of refractory thin endometrium in patients undergoing frozen-thawed embryo transfer. This is based on its ability to stimulate proliferation and angiogenesis with a large number of growth factors and cytokines i.e. the endometrium becomes thicker, with higher vascularity. PRP is easily prepared from an autologous blood sample that eliminates the risk of immunological reactions and transmission infections at low cost.
Read more
Endometrial blood flow is another important marker reflective of uterine receptivity. Although publications are increasing concerning the efficacy of PRP intrauterine infusion on endometrial expansion and proliferation in frozen-thawed embryo transfer cycles, yet its angiogenetic effects have not been evaluated so far in either thin endometrium or normal endometrium thickness.
Our study aims to evaluate endometrial and sub-endometrial vasculature patterns before and after PRP infusion in frozen-thawed embryo transfer cycles with normal endometrium thickness.
- Conditions
- Frozen Embryo Transfer
- Being tested
- Platelet-rich plasma intrauterine infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma intrauterine infusionBiological
For all women, basic transvaginal sonography will be done in the 2nd day of frozen embryo transfer (FET) cycle and they will receive standard hormone replacement therapy (HRT) in the form of estradiol valerate tablets (white tablets of Cyclo-Progynova; Bayer Schering Pharma AG, Germany) at a dose of 4mg for 7 days then 6mg for 6 days. Endometrial assessment will be done on day 15 of FET cycle. Those with endometrial thickness between 8-14 mm will be evaluated for endometrial and sub-endometrial vasculature pattern by 3D power Doppler analysis. Then 1 ml of PRP (prepared from autologous blood) will be infused in the uterine cavity and vaginal progesterone 400 mg twice daily will be prescribed for 3 days. Subsequently, D3 embryos will be transferred. Endometrial, sub-endometrial and uterine arterial vascularity pattern will be re-evaluated on the day of ET. Both estradiol valerate tablets and vaginal progesterone will be continued up to 12th week of gestation in case of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma (PRP) intrauterine infusion | Experimental | Not described Receives: Biological: Platelet-rich plasma intrauterine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularization index of the endometrial region
Vascularization index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis.
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Secondary outcomes (5)
Flow index of the endometrial region
Flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization flow index of the endometrial region
Vascularization flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization index of the sub-endometrial region
Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Flow index of the sub-endometrial region
Flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization flow index of the sub-endometrial region
Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Measured: Day 15 to 18 of the frozen embryo transfer cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start8 Feb 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion5 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frozen Embryo TransferStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, MD. FRCOG. PhD, Study chair, Faculty of Medicine, Mansoura UniversityMohamed Taman, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247204
- Sponsor's protocol ID
- R.20.01.711
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2020
- Last updated
- 29 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nandi A, Martins WP, Jayaprakasan K, Clewes JS, Campbell BK, Raine-Fenning NJ. Assessment of endometrial and subendometrial blood flow in women undergoing frozen embryo transfer cycles. Reprod Biomed Online. 2014 Mar;28(3):343-51. doi: 10.1016/j.rbmo.2013.11.004. Epub 2013 Nov 22.
PubMed 24447958
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Power Doppler Ultrasound Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen-thawed Embryo Transfer Cycles: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04247204
- Acronym / sponsor ID
- R.20.01.711
- Conditions
- Frozen Embryo Transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 8 Feb 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 29 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.
A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. A thin endometrium defined by an endometrial thickness ≤7mm was reported as a poor factor associated with significantly lower implantation and pregnancy rates as well as a higher risk of miscarriage.
Nowadays, platelet-rich plasma (PRP) intrauterine infusion is a promising approach for the treatment of refractory thin endometrium in patients undergoing frozen-thawed embryo transfer. This is based on its ability to stimulate proliferation and angiogenesis with a large number of growth factors and cytokines i.e. the endometrium becomes thicker, with higher vascularity. PRP is easily prepared from an autologous blood sample that eliminates the risk of immunological reactions and transmission infections at low cost.
Endometrial blood flow is another important marker reflective of uterine receptivity. Although publications are increasing concerning the efficacy of PRP intrauterine infusion on endometrial expansion and proliferation in frozen-thawed embryo transfer cycles, yet its angiogenetic effects have not been evaluated so far in either thin endometrium or normal endometrium thickness.
Our study aims to evaluate endometrial and sub-endometrial vasculature patterns before and after PRP infusion in frozen-thawed embryo transfer cycles with normal endometrium thickness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma (PRP) intrauterine infusion | Experimental | Biological: Platelet-rich plasma intrauterine infusion |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.
- Age between 20-35 years.
- Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle
Key exclusion criteria (5 listed)
- Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
- Women with known hematological or immunological disorders
- Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.
- Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.
- Women who refuse to participate in the study.
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 |
|---|---|---|
| Platelet-rich plasma intrauterine infusionFor all women, basic transvaginal sonography will be done in the 2nd day of frozen embryo transfer (FET) cycle and they will receive standard hormone replacement therapy (HRT) in the form of estradiol valerate tablets (white tablets of Cyclo-Progynova; Bayer Schering Pharma AG, Germany) at a dose of 4mg for 7 days then 6mg for 6 days. Endometrial assessment will be done on day 15 of FET cycle. Those with endometrial thickness between 8-14 mm will be evaluated for endometrial and sub-endometrial vasculature pattern by 3D power Doppler analysis. Then 1 ml of PRP (prepared from autologous blood) will be infused in the uterine cavity and vaginal progesterone 400 mg twice daily will be prescribed for 3 days. Subsequently, D3 embryos will be transferred. Endometrial, sub-endometrial and uterine arterial vascularity pattern will be re-evaluated on the day of ET. Both estradiol valerate tablets and vaginal progesterone will be continued up to 12th week of gestation in case of pregnancy. | Biological | Platelet-rich plasma (PRP) intrauterine infusion |
Primary outcome
Vascularization index of the endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis.
5 secondary outcomes
Flow index of the endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization flow index of the endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization index of the sub-endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Flow index of the sub-endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Vascularization flow index of the sub-endometrial region
Time frame: Day 15 to 18 of the frozen embryo transfer cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 24447958Nandi A, Martins WP, Jayaprakasan K, Clewes JS, Campbell BK, Raine-Fenning NJ. Assessment of endometrial and subendometrial blood flow in women undergoing frozen embryo transfer cycles. Reprod Biomed Online. 2014 Mar;28(3):343-51. doi: 10.1016/j.rbmo.2013.11.004. Epub 2013 Nov 22.
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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.
Hatem Abu Hashim, MD. FRCOG. PhD study chair
Faculty of Medicine, Mansoura University
Mohamed Taman, MD principal investigator
Faculty of Medicine, Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma intrauterine infusion in people with Frozen Embryo Transfer, run by Hatem AbuHashim.
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 3 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: status not confirmed, as of the sponsor's last update on 29 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.
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 Hatem Abu Hashim, MD. FRCOG.PhD (+20502300002, hatem_ah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascularization index of the endometrial region (time frame: Day 15 to 18 of the frozen embryo transfer cycle). 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 NCT04247204, 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 29 Jan 2020.