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

Not Applicable

• Conditions: Frozen Embryo Transfer
• Interventions: Biological: Platelet-rich plasma intrauterine infusion

• Registration Number: NCT04247204
• Lead Sponsor: Hatem AbuHashim

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Study First Posted: 2020-01-29
• Last Update Posted: 2020-01-29
• Study Start: 2020-02-08
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.
• Age between 20-35 years.
• Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle

Exclusion Criteria

• Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
• Women with known hematological or immunological disorders
• Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.
• Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.
• Women who refuse to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma (PRP) intrauterine infusion	Platelet-rich plasma intrauterine infusion	-

Primary Outcome Measures

Name	Time	Method
Vascularization index of the endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Vascularization index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis.

Secondary Outcome Measures

Name	Time	Method
Vascularization flow index of the endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Vascularization flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Vascularization index of the sub-endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Flow index of the endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Flow index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Flow index of the sub-endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis
Vascularization flow index of the sub-endometrial region	Day 15 to 18 of the frozen embryo transfer cycle	Vascularization flow index of the sub-endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis