Clinical trial NCT03945812: Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer
Official title: The Impact of Using Granulocyte Colony Stimulating Factor (G-CSF) Versus Platelet Rich Plasma (PRP) on the Outcomes of Frozen Embryo Transfer; Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: GCSF
PRP
Pregnancy
Lead sponsor: Wael Elbanna Clinic
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2019-05-10
Enrollment: 390
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale behind this current study is to assess the impact of using PRP versus GCSF on the outcomes of frozen embryo transfer in term of clinical pregnancy rates.

Detailed description: INTRODUCTION AND STUDY RATIONALE Despite the advancements in the treatment of infertility, repeated failure of implantation continues as a challenging difficulty.

Embryo implantation is affected by many factors. Many efforts were made to improve the implantation rate by different methods blastocyst transfer, assisted hatching, preimplantation genetic screening, hysteroscopy, removal of hydrosalpinges and endometrial scratch. Furthermore, infertility specialists suggested some empirical methods like the infusion in the uterine cavity of platelet-rich plasma (PRP) in patients with thin endometrium which has been shown to be effective in improving the pregnancy rate.

Another factor is granulocyte colony stimulating factor (G-CSF) which has receptors in endometrial cells and may have a role in implantation. The use of G-CSF in assisted reproductive technology (ART) has been tried by many research studies either via intrauterine or systemic administration.

There is only one study compared the impact of PRP and GCSF administration on the pregnancy rate and on the endometrial thickness with a small sample size.

The rationale behind this current study is to assess the impact of using PRP versus GCSF on the outcomes of frozen embryo transfer in term of clinical pregnancy rates.

STUDY OBJECTIVES

Primary:

The primary objective of the study is to compare the clinical pregnancy rate determined by presence of fetal heart beat in transvaginal ultrasound after embryo transfer in all groups.

Secondary:

To compare the following in the three study arms:

* Chemical pregnancy determined by positive serum β-HCG, 2 weeks after embryo transfer.
* Clinical pregnancy rate adjusted by the endometrial thickness (thin versus normal) in all groups.
* Clinical pregnancy rate adjusted by PGS in all groups
* The midluteal endometrial thickness in all groups (histopathology \& TVUS).
* The number of women who had thin endometrium and reaches endometrial thickness ≥ 7 mm after using G-CSF or PRP.
* Implantation rate
* Miscarriage rate
* Live-birth rate

Eligibility criteria: Inclusion Criteria:

* All women aged 20-40 years
* non-smoker
* BMI \< 30
* Normal endometrial cavity confirmed by hysteroscopy
* Visiting the center for IVF by frozen embryo transfer during the period of the study

Exclusion Criteria:

* History of anti-phospholipid syndrome confirmed by serological tests.
* History of any hematological and immunological disorders
* History of chromosomal or genetic abnormalities in the patient or in the family
* Any uterine abnormalities (congenital or acquired)
* Previous uterine surgeries except caesarean section
* Hypersensitivity to G-CSF
* Uncontrolled systemic disease

Primary outcomes:
measure: The clinical pregnancy rate
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Chemical pregnancy rate
timeFrame: Up to 2 weeks
measure: endometrial thickness
timeFrame: Up to 2 weeks
measure: Implantation rate
timeFrame: Up to 2 weeks
measure: Miscarriage rate
timeFrame: With second trimester
measure: Live-birth rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Hayat center
state: Cairo
Study officials:
affiliation: Wael Elbanna Clinic
name: Wael SS Elbanna, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehrafza M, Kabodmehri R, Nikpouri Z, Pourseify G, Raoufi A, Eftekhari A, Samadnia S, Hosseini A. Comparing the Impact of Autologous Platelet-rich Plasma and Granulocyte Colony Stimulating Factor on Pregnancy Outcome in Patients with Repeated Implantation Failure. J Reprod Infertil. 2019 Jan-Mar;20(1):35-41.
citation: Coughlan C, Ledger W, Wang Q, Liu F, Demirol A, Gurgan T, Cutting R, Ong K, Sallam H, Li TC. Recurrent implantation failure: definition and management. Reprod Biomed Online. 2014 Jan;28(1):14-38. doi: 10.1016/j.rbmo.2013.08.011. Epub 2013 Sep 14.
citation: Rinehart J. Recurrent implantation failure: definition. J Assist Reprod Genet. 2007 Jul;24(7):284-7. doi: 10.1007/s10815-007-9147-4. Epub 2007 Aug 3.
citation: Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.