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UnknownNCT04247204

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

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.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Hatem AbuHashim · Academic / Other
Sex
Female
Age
20 Years – 35 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BIOLOGICALPlatelet-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.

Timeline

Start date
2020-02-08
Primary completion
2020-08-31
Completion
2020-10-05
First posted
2020-01-29
Last updated
2020-01-29

Source: ClinicalTrials.gov record NCT04247204. Inclusion in this directory is not an endorsement.