Recurrent Implantation FaliureNCT07306871
Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure
A study testing Platelet rich plasma in people with Recurrent Implantation Faliure and Infertility, run by Minia University at 1 site in Egypt.
Trial summary
Aim of this study is to compare the effectiveness of subendometrial PRP injection \& intrauterine PRP infusion in women with recurrent implantation failure in comparison with a control group . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Implantation Faliure, Infertility
- What is being tested?
- Platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 -40 years .
- BMI<30 Kg/m2.
- An IVF procedure resulting in at least one top quality embryo .
- At least one cancelation history of embryo transfer due to thin endometrium (failure of achieving 7 mm endometrial thickness in the cycle) in frozen embryo transfer (FET) cycles after receiving standard hormone therapy.
- Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.
Who cannot join
- women with other factors that may affect implantation success are excluded: ;
- BMI >30 kg/m2.
- Untreated uterine abnormalities.
- untreated hydrosalpinges.
- Thrombophilia.
- uncontrolled endocrinopathy
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- severe male factor infertility.
- difficult embryo transfer.
- only poor quality embryos available .
- couple with chromosomal abnormalities
- Hematological disorders (blood cancer ,thrombocytopenia )
- Hormonal disorders (DM,thyroid disorders )
- Immunological disorders (anti phospholipid syndrome).
- renal failure
- Genetic ,chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure A Prospective Randomized Controlled Study
Aim of this study is to compare the effectiveness of subendometrial PRP injection \& intrauterine PRP infusion in women with recurrent implantation failure in comparison with a control group .
Read the detailed description
This prospective randomized cotrolled study will be conducted in Private IVF centers in Minia governorate from January 2024 till December 2025,after being approved by the local Ethical committee of the department \& written informed consent will be obtained from participants .
All patients will be counselled regarding inclusion in this study ,a written informed consent will be taken from each patient prior to participation in this study.
Recruited patients will be randomly allocated into 3 groups using opaque sealed closed envelops .
Sample size:
Based on previous studies \& by using the sample size calculation of GPower software version 3.1.9.6 (Franz Faul, Kiel university, Germany), and setting β at 95% and α at 0.05. This makes sample size of 47 per each group. This figure will be rounded 25. Assuming a drop- out rate of 12%, this will make sample size 60 per each group.
(Group1)-(subendometrial PRP group )SE-PRP(n=60): 4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally \& through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET.
(Group 2)-(intrauterine PRP group )IU-PRP(n=60) Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.
(GROUP 3)The control group(n=60) will undergo standard FET with no intervention only hormonal preparation .
Endometrial preparation :
For all groups The Endometrium will be prepared by combined estrogen and progesterone protocol as approved by IVF centeres. Estradiol valerate will be started on day 2/3 of FET cycle at dose of 6mg with measurement of endometrial thickness on the 10 th day of the cycle and every 48 houres \& once endometrium is >7mm progesterone vaginal pessary 400 mg twice daily will be offered for luteal support for 3-5 days then embryos of the same number \& same quality (grade A top quality embryos ) will be transferred in all patients . Estradiol and progesterone will be continued after the transfer till the 12th week of gestational age if pregnancy occurred.
PRP preparation :
PRP will be prepared from autologous blood using a modified two step centrifuge process. , 8.5 ml of peripheral venous blood will be drawn in the syringe that contained 1.5 ml of Acid Citrate A Anticoagulan solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood will be divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat will be collected to another tube and centrifuged again at 3500 g for 5 min to obtain 1.5 ml PRP with 4-5 times more concentrated .
- Conditions
- Recurrent Implantation Faliure, Infertility
- Being tested
- Platelet rich plasma, No intervention /standard care
- Keywords
- Platelet Rich Plasma, Recurrent impantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaBiological
Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
No intervention /standard careOther
Participants will receive standard IVF/ICSI care without platelet-rich plasma administration.
| Study group | Role | What they receive |
|---|---|---|
| Subendometrial PRP group | Active comparator | 4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally \& through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET. Receives: Biological: Platelet rich plasma |
| Intrauterine infusion group | Active comparator | Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm. Receives: Biological: Platelet rich plasma |
| Control group | Active comparator | will undergo standard FET with no intervention only hormonal preparation . Receives: Other: No intervention /standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
the ratio of gestational sacs to the number of embryos transferred .
Measured: 5 weeks after embryo transfer
Secondary outcomes (2)
Chemical pregnancy rate
serum B-hCG 50 IU/L after 14 days from embryo transfer.
Measured: 14 days after embryo transfer
Clinical pregnancy rate
the presence of a gestational sac with heart beat identified by ultrasound 5 weeks after the embryo transfer.
Measured: 5 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 posted29 Dec 2025
- Study start1 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FaliureStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed mouner saber, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306871
- Sponsor's protocol ID
- 1551991
- Status last verified
- May 2025
- First submitted
- 14 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07306871
- Acronym / sponsor ID
- 1551991
- Conditions
- Recurrent Implantation Faliure, Infertility
- Keywords
- Platelet Rich Plasma, Recurrent impantation failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (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 this study is to compare the effectiveness of subendometrial PRP injection \& intrauterine PRP infusion in women with recurrent implantation failure in comparison with a control group .
Detailed description
This prospective randomized cotrolled study will be conducted in Private IVF centers in Minia governorate from January 2024 till December 2025,after being approved by the local Ethical committee of the department \& written informed consent will be obtained from participants .
All patients will be counselled regarding inclusion in this study ,a written informed consent will be taken from each patient prior to participation in this study.
Recruited patients will be randomly allocated into 3 groups using opaque sealed closed envelops .
Sample size:
Based on previous studies \& by using the sample size calculation of GPower software version 3.1.9.6 (Franz Faul, Kiel university, Germany), and setting β at 95% and α at 0.05. This makes sample size of 47 per each group. This figure will be rounded 25. Assuming a drop- out rate of 12%, this will make sample size 60 per each group.
(Group1)-(subendometrial PRP group )SE-PRP(n=60): 4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally \& through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET.
(Group 2)-(intrauterine PRP group )IU-PRP(n=60) Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.
(GROUP 3)The control group(n=60) will undergo standard FET with no intervention only hormonal preparation .
Endometrial preparation :
For all groups The Endometrium will be prepared by combined estrogen and progesterone protocol as approved by IVF centeres. Estradiol valerate will be started on day 2/3 of FET cycle at dose of 6mg with measurement of endometrial thickness on the 10 th day of the cycle and every 48 houres \& once endometrium is >7mm progesterone vaginal pessary 400 mg twice daily will be offered for luteal support for 3-5 days then embryos of the same number \& same quality (grade A top quality embryos ) will be transferred in all patients . Estradiol and progesterone will be continued after the transfer till the 12th week of gestational age if pregnancy occurred.
PRP preparation :
PRP will be prepared from autologous blood using a modified two step centrifuge process. , 8.5 ml of peripheral venous blood will be drawn in the syringe that contained 1.5 ml of Acid Citrate A Anticoagulan solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood will be divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat will be collected to another tube and centrifuged again at 3500 g for 5 min to obtain 1.5 ml PRP with 4-5 times more concentrated .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subendometrial PRP group | Active comparator | Biological: Platelet rich plasma4 ml PRP will be injected in this group into the sub endometrial space(1-2 ml)below endometrium at multiple sites trans vaginally \& through the cervix after insertion of a cuscow speculum via ovum pick up needle under ultrasound guidance in the luteal phase of previous cycle of FET. |
| Intrauterine infusion group | Active comparator | Biological: Platelet rich plasmaIntrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm. |
| Control group | Active comparator | Other: No intervention /standard carewill undergo standard FET with no intervention only hormonal preparation . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 -40 years .
- BMI<30 Kg/m2.
- An IVF procedure resulting in at least one top quality embryo .
- At least one cancelation history of embryo transfer due to thin endometrium (failure of achieving 7 mm endometrial thickness in the cycle) in frozen embryo transfer (FET) cycles after receiving standard hormone therapy.
- Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.
Key exclusion criteria (15 listed)
- women with other factors that may affect implantation success are excluded: ;
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 plasmaAutologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer. | Biological | Intrauterine infusion group, Subendometrial PRP group |
| No intervention /standard careParticipants will receive standard IVF/ICSI care without platelet-rich plasma administration. | Other | Control group |
Primary outcome
Implantation rate
Time frame: 5 weeks after embryo transfer
the ratio of gestational sacs to the number of embryos transferred .
2 secondary outcomes
Chemical pregnancy rate
Time frame: 14 days after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma in people with Recurrent Implantation Faliure and Infertility, run by Minia University 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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Implantation rate (time frame: 5 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 10 Mar 2026.