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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

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

Clinicaltrials.gov identifier NCT03945812

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted July 21, 2020

Study Description

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.

  • Condition or Disease:Infertility
  • Intervention/Treatment: Drug: Granulocyte Colony Stimulating Factor
    Other: Platelet Rich Plasma Arm
    Other: Saline
  • Phase: Phase 4
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 390 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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)
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
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.
Drug: Granulocyte Colony Stimulating Factor
Filgrastim, Amgen, California, USA 300 mg/1.0 mL
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.
Other: Platelet Rich Plasma Arm
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.
Other: Saline
Saline 9%
Outcome Measures
  • Primary Outcome Measures: 1. The clinical pregnancy rate [ Time Frame: Up to 2 weeks ]
    The clinical pregnancy rate
  • Secondary Outcome Measures: 1. Chemical pregnancy rate [ Time Frame: Up to 2 weeks ]
    Chemical pregnancy rate
  • 2. endometrial thickness [ Time Frame: Up to 2 weeks ]
    endometrial thickness in all groups (histopathology & TVUS)
  • 3. Implantation rate [ Time Frame: Up to 2 weeks ]
    Implantation rate
  • 4. Miscarriage rate [ Time Frame: With second trimester ]
    Miscarriage rate
  • 5. Live-birth rate [ Time Frame: 1 year ]
    Live-birth rate
Eligibility Criteria
  • Ages Eligible for Study: 20 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Emad RH Issak, Dip 00201272228989 dr.emad.r.h.issak@gmail.com

Contact: Wael SS Elbanna, MD 00201227760402

Locations

Egypt, Cairo
Wael El-Banna Clinic
Maadi

Sponsors and Collaborators

ClinAmygate

Wael Elbanna Clinic

National Research Center, Egypt

Investigators

Study Director: Emad RH Issak, Dip ClinAmygate