Clinical trial NCT04247204: Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Embryo Transfer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vascularization index of the endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
Secondary outcomes:
measure: Flow index of the endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
measure: Vascularization flow index of the endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
measure: Vascularization index of the sub-endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
measure: Flow index of the sub-endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
measure: Vascularization flow index of the sub-endometrial region
timeFrame: Day 15 to 18 of the frozen embryo transfer cycle
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Hatem Abu Hashim, MD. FRCOG. PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Mansoura University
name: Mohamed Taman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nandi A, Martins WP, Jayaprakasan K, Clewes JS, Campbell BK, Raine-Fenning NJ. Assessment of endometrial and subendometrial blood flow in women undergoing frozen embryo transfer cycles. Reprod Biomed Online. 2014 Mar;28(3):343-51. doi: 10.1016/j.rbmo.2013.11.004. Epub 2013 Nov 22.