Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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 Intervention/treatment Phase
Infertility Drug: Granulocyte Colony Stimulating Factor Other: Platelet Rich Plasma Arm Other: Saline 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 15, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


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
Other Name: Filgrastim

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%
Other Name: Saline 9%




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945812


Contacts
Layout table for location contacts
Contact: Emad RH Issak, Dip 00201272228989 dr.emad.r.h.issak@gmail.com
Contact: Wael SS Elbanna, MD 00201227760402

Locations
Layout table for location information
Egypt
Wael El-Banna Clinic Recruiting
Maadi, Cairo, Egypt
Contact: Wael SS El-Banna, MD         
Sponsors and Collaborators
ClinAmygate
Wael Elbanna Clinic
National Research Centre, Egypt
Investigators
Layout table for investigator information
Study Director: Emad RH Issak, Dip ClinAmygate
Publications:
Layout table for additonal information
Responsible Party: Emad Roushdy, Director, ClinAmygate
ClinicalTrials.gov Identifier: NCT03945812    
Other Study ID Numbers: INDV-0909012
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Roushdy, ClinAmygate:
GCSF
PRP
Pregnancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs