A RCT on the Effect of Platelets Rich Plasma in ICSI Patients With Recurrent Implantation Failure

NCT04434547 | Unknown Phase 2

• 1 other identifier: DrHGouda
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will be performed on 86 patients with recurrent implantation failure at Dar El Teb infertility and IVF center . Patients were randomized on a 1 to 1 ratio to platelets rich plasma ( PRP) group and control group. Ovarian stimulation was achieved using highly purified urinary FSH starting on the 2 nd or 3rd day of the cycle . GnRH agonist ( cetrotide) 0.25 mg SC/ day was administered when the leading follicle reached 14mm in mean diameter and a dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in diameter.. Oocyte retrieval was done under ultrasound guidance and in the PRP group 1 ml of platelets rich plasma was infused inside the uterus while performing the mock embryo transfer while in the control group the mock embryo transfer was performed without injecting anything inside the uterus . All patients received progesterone supplementation and embryo transfer was performed 3 to 5 days after oocyte retrieval. BHCG level was done 14 days after Embryo transfer and transvaginal ultrasound was done to confirm pregnancy 4 weeks later.

Conditions

Pregnancy Outcome

Keywords

PRP , IVF

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  The presence of a gestational sac by transvaginal ultrasound

  Four weeks post intervention

Secondary Outcomes (3)

• Implantation rate

  Four weeks post intervention

• Ongoing pregnancy rate

  Five months post intervention

• Abortion rate

  Five months post intervention

Study Arms (2)

PRP group

EXPERIMENTAL

In the PRP group autologous platelets rich plasma was prepared from the blood using the two step centifuge process .Under ultrasound guidance and complete aseptic procedure , 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer

Biological: PRP

Control group

NO INTERVENTION

In the control group mock embryo transfer was performed without injecting anything inside the uterus.

Interventions

PRP BIOLOGICAL

During the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus

Also known as: Platelets rich plasma

PRP group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with history of three or more unsuccessful IVF-ET cycles with at least two good quality embryos transferred and candidates for fresh embryo transfer

You may not qualify if:

• Age less than 18 years or more than 35years and body mass index more than 30 kg/m2.
• Patients with PCOS, endometriosis, uterine anomalies , Ashermann syndrome, chronic endometritis, chromosomal abnormalities, increased peripheral NK cells, hereditary thrombophylia and anti phospholipid syndrome

Sponsors & Collaborators

• Dr. Osman Hospital: lead

Related Publications (1)

• Nazari L, Salehpour S, Hosseini MS, Hashemi Moghanjoughi P. The effects of autologous platelet-rich plasma in repeated implantation failure: a randomized controlled trial. Hum Fertil (Camb). 2020 Sep;23(3):209-213. doi: 10.1080/14647273.2019.1569268. Epub 2019 Feb 4.

  PMID: 30714427 BACKGROUND

Study Officials

• Hisham Gouda, MD

  Assistant prof Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham Gouda, MD

CONTACT

00201001885885; Sheemeer75@gmail.com

Omneya Osman, MD

CONTACT

01006671777; Omna03@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant prof OB/GYN Cairo university

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: June 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: March 15, 2021
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share