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

NCT ID: NCT04247204

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-08
• Study Completion Date: 2020-10-05

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.

Conditions

Frozen Embryo Transfer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Platelet-rich plasma (PRP) intrauterine infusion

Group Type: EXPERIMENTAL

Platelet-rich plasma intrauterine infusion

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hatem AbuHashim

OTHER

Sponsor Role: lead

Responsible Party

Hatem AbuHashim

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatem Abu Hashim, MD. FRCOG. PhD

Role: STUDY_CHAIR

Faculty of Medicine, Mansoura University

Mohamed Taman, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Mansoura University

Central Contacts

Hatem Abu Hashim, MD. FRCOG.PhD

Role: CONTACT

hatem_ah@hotmail.com

+20502300002

References

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.

Reference Type: BACKGROUND

PMID: 24447958 (View on PubMed)

Other Identifiers

R.20.01.711

Identifier Type: -

Identifier Source: org_study_id