Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure .A Prospective Randomized Controlled Study
NCT ID: NCT07306871
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
180 participants
INTERVENTIONAL
2026-01-01
2026-12-31
Brief Summary
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Detailed Description
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Inclusion criteria: patients with the following inclusion criteria will be included in the study :Women with history of unexplained RIF undergoing Frozen Embryo transfer (FET) were recruited including following criteria :
1. Age 18 -40 years
2. BMI\<30 Kg/m2
3. An IVF procedure resulting in at least one top quality embryo
4. 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.
5. Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.
Exclusion criteria:
women with other factors that may affect implantation success are excluded: ; BMI \>30 kg/m2, Untreated uterine abnormalities, untreated hydrosalpinges, Thrombophilia, uncontrolled endocrinopathy 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
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.
The FET cycle will be cancelled if the endometrial thickness doesn't reach to 7 mm or above in all groups until 17th cycle day, ultimately.
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 . \[
The implantation rate was defined as the ratio of gestational sacs to the number of embryos transferred .
The chemical pregnancy was defined as serum B-hCG 50 IU/L after 14 days from embryo transfer.
the clinical pregnancy as the presence of a gestational sac with heart beat identified by ultrasound 5 weeks after the embryo transfer.
Outcome measures :
The main outcome measures are:
the implantation rate . Chemical pregnancy rate. Clinical pregnancy rate.
All will be compared between all groups of patients
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subendometrial PRP group
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.
Platelet rich plasma
Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
Intrauterine infusion group
Intrauterine infusion of 4 ml PRP will be done during FET cycle when endometrium reaches 7 mm.
Platelet rich plasma
Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
Control group
will undergo standard FET with no intervention only hormonal preparation .
No intervention /standard care
Participants will receive standard IVF/ICSI care without platelet-rich plasma administration.
Interventions
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Platelet rich plasma
Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.
No intervention /standard care
Participants will receive standard IVF/ICSI care without platelet-rich plasma administration.
Eligibility Criteria
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Inclusion Criteria
5-Women had a history of failure to achieve pregnancy after two or more embryo transfers with high-quality embryos.
Exclusion Criteria
* BMI \>30 kg/m2,
* Untreated uterine abnormalities, untreated hydrosalpinges,
* Thrombophilia, uncontrolled endocrinopathy
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Minia University
OTHER
Responsible Party
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Mohamed mouner saber
Assistant lecturer
Locations
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Minia University
Minya, , Egypt
Countries
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Central Contacts
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Other Identifiers
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1551991
Identifier Type: -
Identifier Source: org_study_id