Subendometrial Injection Versus Intrauterine Infusion of Platelet Rich Plasma for Women With Recurrent Implantation Failure

NCT07306871 | Active Not Recruiting DMC

• 1 other identifier: 1551991
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Infertility; Recurrent Implantation Faliure

Keywords

Platelet Rich Plasma; Recurrent impantation failure

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  the ratio of gestational sacs to the number of embryos transferred .

  5 weeks after embryo transfer

Secondary Outcomes (2)

• Chemical pregnancy rate

  14 days after embryo transfer

• Clinical pregnancy rate

  5 weeks after embryo transfer

Study Arms (3)

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.

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.

Biological: Platelet rich plasma

Control group

ACTIVE COMPARATOR

will undergo standard FET with no intervention only hormonal preparation .

Other: No intervention /standard care

Interventions

Platelet rich plasma BIOLOGICAL

Autologous platelet-rich plasma prepared from peripheral blood and administered either by subendometrial injection or intrauterine infusion prior to embryo transfer.

Intrauterine infusion group; Subendometrial PRP group

No intervention /standard care OTHER

Participants will receive standard IVF/ICSI care without platelet-rich plasma administration.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)