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Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer

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ClinicalTrials.gov Identifier: NCT03945812
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Wael Elbanna Clinic
National Research Centre, Egypt
Information provided by (Responsible Party):
Emad Roushdy, ClinAmygate

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
The clinical pregnancy rate [ Time Frame: Up to 2 weeks ]
The clinical pregnancy rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Chemical pregnancy rate [ Time Frame: Up to 2 weeks ]
    Chemical pregnancy rate
  • endometrial thickness [ Time Frame: Up to 2 weeks ]
    endometrial thickness in all groups (histopathology & TVUS)
  • Implantation rate [ Time Frame: Up to 2 weeks ]
    Implantation rate
  • Miscarriage rate [ Time Frame: With second trimester ]
    Miscarriage rate
  • Live-birth rate [ Time Frame: 1 year ]
    Live-birth rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Granulocyte Colony Stimulating Factor Versus Platelet Rich Plasma and Outcomes of Frozen Embryo Transfer
Official Title  ICMJE The Impact of Using Granulocyte Colony Stimulating Factor (G-CSF) Versus Platelet Rich Plasma (PRP) on the Outcomes of Frozen Embryo Transfer; Double-blinded Randomized Placebo-controlled Trial (Endotrial)
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.
  • 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Granulocyte Colony Stimulating Factor
    Filgrastim, Amgen, California, USA 300 mg/1.0 mL
    Other Name: Filgrastim
  • Other: Platelet Rich Plasma Arm
    Platelet Rich Plasma Arm
  • Other: Saline
    Saline 9%
    Other Name: Saline 9%
Study Arms  ICMJE
  • Active Comparator: Granulocyte Colony Stimulating Factor Arm

    Women in this group will receive G-CSF with conventional hormonal therapy:

    Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.

    Intervention: Drug: Granulocyte Colony Stimulating Factor
  • Active Comparator: Platelet Rich Plasma Arm

    Women in this group will receive PRP with conventional hormonal therapy:

    Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.

    Intervention: Other: Platelet Rich Plasma Arm
  • Placebo Comparator: Saline

    Women in this group will receive saline with conventional hormonal therapy:

    Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer cycle will be performed.

    Intervention: Other: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date June 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All women aged 20-40 years
  • non-smoker
  • BMI < 30
  • Normal endometrial cavity confirmed by hysteroscopy

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emad RH Issak, Dip 00201272228989 dr.emad.r.h.issak@gmail.com
Contact: Wael SS Elbanna, MD 00201227760402
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945812
Other Study ID Numbers  ICMJE INDV-0909012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emad Roushdy, ClinAmygate
Study Sponsor  ICMJE ClinAmygate
Collaborators  ICMJE
  • Wael Elbanna Clinic
  • National Research Centre, Egypt
Investigators  ICMJE
Study Director: Emad RH Issak, Dip ClinAmygate
PRS Account ClinAmygate
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP