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

Pregnancy Outcome Clinical Trial

— PRP  

Official title:

A Randomized Controlled Trial on the Effect of Adding Platelets Rich Plasma Intrauterine on the Day of Ovum Pickup in ICSI Patients With Recurrent Implantation Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04434547
• Other study ID #: DrHGouda
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: June 2020
• Source: Dr. Osman Hospital
• Contact: Hisham Gouda, MD
• Phone: 00201001885885
• Email: Sheemeer75[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This two arm, allocation concealed ,assessor blinded randomized controlled trial is to be conducted at Dar ElTeb Infertility and IVF center ,Giza,Egypt between the period between June 2020 and March 2021.

Eighty six patients with recurrent implantation failure were randomized in a 1 to 1 ratio to platelets-rich plasma (PRP) group and the control group . Patients were randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation written on a card. The randomization list and the sealed envelopes were prepared by a colleague who is not directly involved in the study . The embryologists and the doctors responsible for follow up of the patients after ovum pickup were blinded to received treatment.

Ovarian stimulation was achieved using highly purified urinary FSH ( HPuFSH) (Fostimon,IBSA, Switzerland) started on the 2nd or 3rd day of menstruation . The initial dose of HPuFSH ranged between 150 and 300 IU/day depending on expected ovarian response. The dose of HPuFSH was modified from stimulation day 5 in steps of 75 units every 2nd or 3rd day depending on serum E2 and follicular development assessed by transvaginal ultrasound.

GnRH agonist ( cetrolix acetate) (cetrotide) 0.25mg SC/day was administered when the leading follicle reached 14 mm in mean diameter and was continued until and including the day of HCG administration .

A dose of 10000 IU of HCG was administered when 3 or more follicles were 18mm or more in mean diameter .

Oocyte retrieval under transvaginal ultrasound guidance was performed 34 hours after HCG administration .

In PRP group autologous platelets rich plasma was prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures ,the endometrial thickness was measured then 1 ml of PRP was infused inside the uterus while performing the mock embryo transfer . In the control group mock embryo transfer was performed without injecting anything inside the uterus .

All the patients received progesterone vaginal pessaries ( prontogest, Marcyryl, Egypt) 400mg twice daily , starting on the day of oocyte retrieval and continuing until 12 weeks gestation or negative pregnancy test.

No more than 3 embryos were transferred under ultrasound guidance 3 to 5 days after oocyte retrieval . B HCG level was detected in blood 14 days after Embryo transfer to confirm pregnancy and transvaginal ultrasound was performed 4 weeks after embryo transfer to confirm clinical pregnancy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: March 15, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pregnancy Outcome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Osman Hospital

References & 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). 2019 Feb 4:1-5. doi: 10.1080/14647273.2019.1569268. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	The presence of a gestational sac by transvaginal ultrasound	Four weeks post intervention
Secondary	Implantation rate	The number of gestational sacs detected by ultrasound divided by the number of embryos	Four weeks post intervention
Secondary	Ongoing pregnancy rate	Pregnancies continuing beyond the 20th week	Five months post intervention
Secondary	Abortion rate	Pregnancies terminated before 20 weeks	Five months post intervention