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Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles

NCT04247204 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-29

No results posted yet for this study

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. 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.

Conditions

  • Frozen Embryo Transfer

Interventions

BIOLOGICAL

Platelet-rich plasma intrauterine infusion

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.

Sponsors & Collaborators

  • Hatem AbuHashim

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim, MD. FRCOG. PhD · Faculty of Medicine, Mansoura University

  • Mohamed Taman, MD · Faculty of Medicine, Mansoura University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-08
Primary Completion
2020-08-31
Completion
2020-10-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04247204 on ClinicalTrials.gov