InfertilityPhase 4NCT03945812
Platelet-Rich Plasma vs. Granulocyte Colony-Stimulating Factor vs. Placebo and Outcomes in Frozen Embryo Transfer
A Phase 4 study testing Granulocyte Colony Stimulating Factor, Platelet Rich Plasma Arm and Saline in people with Infertility and Frozen Embryo Transfer (FET), run by Wael Elbanna Clinic at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the impact of using Platelet-Rich Plasma (PRP) vs. Granulocyte Colony-Stimulating Factor (GCSF) vs. placebo on the outcomes of frozen embryo transfer (FET) in terms of clinical pregnancy rates. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Frozen Embryo Transfer (FET)
- What is being tested?
- Granulocyte Colony Stimulating Factor, Platelet Rich Plasma Arm and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 665 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 8 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women aged 20-40 years
- Non-smoker
- BMI < 30
- Normal endometrial cavity confirmed by hysteroscopy and ultrasound
- Visiting the center for IVF by FET during the period of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Using Platelet-Rich Plasma Versus Granulocyte Colony-Stimulating Factor Versus Placebo on the Outcomes of Frozen Embryo Transfer: A Double Blind Randomized Controlled Trial
The goal of this clinical trial is to assess the impact of using Platelet-Rich Plasma (PRP) vs. Granulocyte Colony-Stimulating Factor (GCSF) vs. placebo on the outcomes of frozen embryo transfer (FET) in terms of clinical pregnancy rates. It will also assess their effect on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters.
The main questions it aims to answer are:
Read more
Do the clinical pregnancy rates differ upon using PRP vs. GCSF vs. placebo during FET? What are the effects of PRP vs. GCSF vs. placebo during FET on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters?
Researchers will compare the effect of administration of PRP vs. GCSF vs. placebo during FET on pregnancy outcomes.
Participants will be randomized to receive the study intervention seven days before embryo transfer: 1.0 ml of either PRP (prepared in-house), GCSF (Filgrastim, 300 mcg/1.0 mL), or 0.9% saline (placebo). The intervention will be administered by slow infusion into the uterine cavity with an intrauterine insemination catheter.
Read the 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 (GCSF) which has receptors in endometrial cells and may have a role in implantation. The use of GCSF in assisted reproductive technology (ART) has been tried by many research studies either via intrauterine or systemic administration.
There are limited studies that 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 versus on the outcomes of FET in terms of 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 6 weeks of 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.
- Delivery outcomes: miscarriage and live bith rates.
- The implantation rate, calculated by dividing the number of gestational sacs observed via ultrasound by the number of embryos transferred.
- The change in endometrial parameters, assessed as endometrial thickness, Doppler indices, endometrial vascularization, blood volume histogram indices, and the histological dating of the endometrium.
SAMPLE SIZE CALCULATION The sample size was calculated using G*Power 3.1.9.7. Based on Jie Li et al. study, the clinical pregnancy rate in the GCSF group was 25.1% compared to 14.4% in the placebo or no-treatment group. Assuming a 10% improvement in the clinical pregnancy rate with GCSF, a two-sided alpha level of 5%, and achieving 80% power, the sample size was initially calculated to be 498 women. To account for a 25% anticipated dropout rate, the final sample size was adjusted to 624 women (208 in each group). Although no studies comparing PRP to placebo, specifically in our study population, were published before designing our study, a 22% improvement in the clinical pregnancy rate with PRP was observed in studies involving women with thin endometrium. To reach sufficient power to detect differences between the three study arms, our calculation was based on GCSF.
Li J, Mo S, Chen Y. The effect of G-CSF on infertile women undergoing IVF treatment: A meta-analysis. Systems Biology in Reproductive Medicine. 2017/07/04 2017;63(4):239-247. doi:10.1080/19396368.2017.1287225
STATISTICAL ANALYSIS We will compare participants' baseline demographics and clinical characteristics across the study's three arms: PRP, GCSF, and saline. Categorical variables will be presented as frequency and percentage and compared using the Chi-squared test (χ2). Normally distributed variables will be reported as mean (standard deviation; SD) and compared using one-way analysis of variance (ANOVA), while non-normally distributed will be reported as median (25th to 75th percentile) and compared using the Kruskal-Wallis test. A p-value of less than 0.05 will be considered statistically significant.
Clinical pregnancy rate will be adjusted by the endometrial thickness (thin versus normal (≥ 7 mm)) in all groups.
An interim analysis will be conducted by the Data Monitoring Committee (DMC) after 60% of participants have been enrolled in the study to assess the efficacy of the intervention arms.
SUB-GROUP ANALYSIS: to evaluate the clinical pregnancy rates among patients based on:
- Anti-Müllerian hormone (AMH) value <1 ng/ml (poor responders)
- Preimplantation genetic screening (PGS)
- Reepeated, two or more, failed implantations (RIF).
- Triple-layered endometrium, evaluated by TVUS in the mid-luteal phase.
- Conditions
- Infertility, Frozen Embryo Transfer (FET)
- Being tested
- Granulocyte Colony Stimulating Factor, Platelet Rich Plasma Arm, Saline
- Keywords
- GCSF, PRP, Pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony Stimulating FactorDrug
Also called Filgrastim
Filgrastim, Amgen, California, USA 300 mg/1.0 mL
Platelet Rich Plasma ArmOther
Platelet Rich Plasma Arm
SalineOther
Also called Saline 9%
Saline 9%
| Study group | Role | What they receive |
|---|---|---|
| Granulocyte Colony Stimulating Factor Arm | Active comparator | Women in this group will receive GCSF with conventional hormonal therapy:
Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed. Receives: Drug: Granulocyte Colony Stimulating Factor |
| Platelet Rich Plasma Arm | Active comparator | 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 will be performed. Receives: Other: Platelet Rich Plasma Arm |
| Saline | Placebo comparator | 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 will be performed. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical pregnancy rate
Definition: The presence of fetal heartbeats in transvaginal ultrasound after 6 to 8 weeks of embryo transfer in all groups.
Unit of Measure: The percentage of participants who will achieve a clinical pregnancy among those who underwent the embryo transfer, calculated by dividing the number of participants who will have a clinical pregnancy by the total number of participants who underwent embryo transfer and multiplying by 100.
Measured: 6 to 8 weeks of embryo transfer
Secondary outcomes (10)
Chemical pregnancy rate
Definition: Positive serum β-hCG 2 weeks post-embryo transfer.
Unit of Measure: The percentage of participants who will achieve a chemical pregnancy among those who underwent the embryo transfer, calculated by dividing the number of participants who will have a chemical pregnancy by the total number of participants who underwent embryo transfer and multiplying by 100.
Measured: 2 weeks post embryo transfer
Miscarriage rate
Definition: Loss of a clinical pregnancy before 20 weeks of gestation.
Unit of Measure: The percentage of participants who will have a miscarriage among those who achieved clinical pregnancy, calculated by dividing the number of participants who will have a miscarriage by the total number of participants who achieved clinical pregnancy and multiplying by 100.
Measured: 20 weeks of gestation
Live-birth rate
Definition: the number of deliveries that resulted in a live-born neonate.
Unit of Measure: The percentage of participants who will have a live-born neonate among those who achieved clinical pregnancy, calculated by dividing the number of participants who will have a live-born neonate by the total number of participants who achieved clinical pregnancy and multiplying by 100.
Measured: The live birth rate is assessed at the time of birth, including both full-term and preterm live births.
Implantation rate
Definition: Number of gestational sacs observed via transvaginal ultrasound divided by number of embryos transferred.
Unit of Measure: Ratio (sacs/embryos)
Measured: Between 3 and 5 weeks after embryo transfer.
Endometrial Thickness
Endometrial thickness is measured as the maximum anterior-posterior thickness (in mm) of the endometrial echo on a long-axis transvaginal view of the uterus using transvaginal ultrasound.
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Uterine Artery Doppler Indices (e.g., PI, RI)
Assessment of uterine artery blood flow resistance using Doppler ultrasound. Pulsatility Index (PI) and Resistance Index (RI) are the main Doppler indices used. Units: Both PI and RI are dimensionless (no units), as they are ratios derived from velocity measurements. Typical reporting: PI and RI are given as numeric values (e.g., PI = 1.75, RI = 0.72).
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Endometrial Vascularization
Endometrial Vascularization Tool: 3D Power Doppler histogram. Measured as: Microvessel Density (MVD) and Vascular Endothelial Growth Factor (VEGF) expression. Units: MVD; number of microvessels per square millimeter, VEGF H-score; semi-quantitative, unitless score based on staining intensity.
Blood Volume Histogram Indices: Vascularization Index (VI), Flow Index (FI), Vascularization-Flow Index (VFI) are the main indices. Units: These indices are dimensionless (unitless ratios or percentages) as they are calculated from the proportion or intensity of power Doppler signals within a defined volume.
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histogram Indices (Blood flow velocities)
Definition: Histograms in medical imaging often display the distribution of blood flow velocities.
Units: cm/s or mL/min (velocity or volume flow rate).
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histogram Indices (cell sizes)
Definition: Histograms in medical imaging often display the distribution of cell sizes.
Units: femtoliters (fL) for mean cell volume
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histological Dating of Endometrium
Microscopic assessment to determine phase consistency with expected luteal day using histological biopsy, assessed via Noyes criteria. Unit: Luteal phase date match (yes/no or deviation in days). Units: Days of the menstrual cycle (e.g., Day 17, Day 19), or described by phase (proliferative, secretory, etc.). No physical units are assigned to histological dating; it is a temporal or qualitative assessment based on morphological criteria
Measured: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jun 2019
- Primary completion31 Mar 2022
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wael Elbanna Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
- Investigators
- Wael SS Elbanna, Consultant, Principal investigator, Wael Elbanna Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945812
- Sponsor's protocol ID
- INDV-0909012
- Status last verified
- Jul 2025
- First submitted
- 8 May 2019
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30859080Coughlan 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.
PubMed 24269084Rinehart 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.
PubMed 17674185Chang 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.
PubMed 25785127
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Platelet-Rich Plasma Versus Granulocyte Colony-Stimulating Factor Versus Placebo on the Outcomes of Frozen Embryo Transfer: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03945812
- Acronym / sponsor ID
- INDV-0909012
- Conditions
- Infertility, Frozen Embryo Transfer (FET)
- Keywords
- GCSF, PRP, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Wael Elbanna ClinicUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the impact of using Platelet-Rich Plasma (PRP) vs. Granulocyte Colony-Stimulating Factor (GCSF) vs. placebo on the outcomes of frozen embryo transfer (FET) in terms of clinical pregnancy rates. It will also assess their effect on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters.
The main questions it aims to answer are:
Do the clinical pregnancy rates differ upon using PRP vs. GCSF vs. placebo during FET? What are the effects of PRP vs. GCSF vs. placebo during FET on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters?
Researchers will compare the effect of administration of PRP vs. GCSF vs. placebo during FET on pregnancy outcomes.
Participants will be randomized to receive the study intervention seven days before embryo transfer: 1.0 ml of either PRP (prepared in-house), GCSF (Filgrastim, 300 mcg/1.0 mL), or 0.9% saline (placebo). The intervention will be administered by slow infusion into the uterine cavity with an intrauterine insemination catheter.
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 (GCSF) which has receptors in endometrial cells and may have a role in implantation. The use of GCSF in assisted reproductive technology (ART) has been tried by many research studies either via intrauterine or systemic administration.
There are limited studies that 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 versus on the outcomes of FET in terms of 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 6 weeks of 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.
- Delivery outcomes: miscarriage and live bith rates.
- The implantation rate, calculated by dividing the number of gestational sacs observed via ultrasound by the number of embryos transferred.
- The change in endometrial parameters, assessed as endometrial thickness, Doppler indices, endometrial vascularization, blood volume histogram indices, and the histological dating of the endometrium.
SAMPLE SIZE CALCULATION The sample size was calculated using G*Power 3.1.9.7. Based on Jie Li et al. study, the clinical pregnancy rate in the GCSF group was 25.1% compared to 14.4% in the placebo or no-treatment group. Assuming a 10% improvement in the clinical pregnancy rate with GCSF, a two-sided alpha level of 5%, and achieving 80% power, the sample size was initially calculated to be 498 women. To account for a 25% anticipated dropout rate, the final sample size was adjusted to 624 women (208 in each group). Although no studies comparing PRP to placebo, specifically in our study population, were published before designing our study, a 22% improvement in the clinical pregnancy rate with PRP was observed in studies involving women with thin endometrium. To reach sufficient power to detect differences between the three study arms, our calculation was based on GCSF.
Li J, Mo S, Chen Y. The effect of G-CSF on infertile women undergoing IVF treatment: A meta-analysis. Systems Biology in Reproductive Medicine. 2017/07/04 2017;63(4):239-247. doi:10.1080/19396368.2017.1287225
STATISTICAL ANALYSIS We will compare participants' baseline demographics and clinical characteristics across the study's three arms: PRP, GCSF, and saline. Categorical variables will be presented as frequency and percentage and compared using the Chi-squared test (χ2). Normally distributed variables will be reported as mean (standard deviation; SD) and compared using one-way analysis of variance (ANOVA), while non-normally distributed will be reported as median (25th to 75th percentile) and compared using the Kruskal-Wallis test. A p-value of less than 0.05 will be considered statistically significant.
Clinical pregnancy rate will be adjusted by the endometrial thickness (thin versus normal (≥ 7 mm)) in all groups.
An interim analysis will be conducted by the Data Monitoring Committee (DMC) after 60% of participants have been enrolled in the study to assess the efficacy of the intervention arms.
SUB-GROUP ANALYSIS: to evaluate the clinical pregnancy rates among patients based on:
- Anti-Müllerian hormone (AMH) value <1 ng/ml (poor responders)
- Preimplantation genetic screening (PGS)
- Reepeated, two or more, failed implantations (RIF).
- Triple-layered endometrium, evaluated by TVUS in the mid-luteal phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Granulocyte Colony Stimulating Factor Arm | Active comparator | Drug: Granulocyte Colony Stimulating FactorWomen in this group will receive GCSF with conventional hormonal therapy: Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed. |
| Platelet Rich Plasma Arm | Active comparator | Other: Platelet Rich Plasma ArmWomen 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 will be performed. |
| Saline | Placebo comparator | Other: SalineWomen 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 will be performed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All women aged 20-40 years
- Non-smoker
- BMI < 30
- Normal endometrial cavity confirmed by hysteroscopy and ultrasound
- Visiting the center for IVF by FET during the period of the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte Colony Stimulating FactorAlso: FilgrastimFilgrastim, Amgen, California, USA 300 mg/1.0 mL | Drug | Granulocyte Colony Stimulating Factor Arm |
| Platelet Rich Plasma ArmPlatelet Rich Plasma Arm | Other | Platelet Rich Plasma Arm |
| SalineAlso: Saline 9%Saline 9% | Other | Saline |
Primary outcome
The clinical pregnancy rate
Time frame: 6 to 8 weeks of embryo transfer
Definition: The presence of fetal heartbeats in transvaginal ultrasound after 6 to 8 weeks of embryo transfer in all groups. Unit of Measure: The percentage of participants who will achieve a clinical pregnancy among those who underwent the embryo transfer, calculated by dividing the number of participants who will have a clinical pregnancy by the total number of participants who underwent embryo transfer and multiplying by 100.
10 secondary outcomes
Chemical pregnancy rate
Time frame: 2 weeks post embryo transfer
Miscarriage rate
Time frame: 20 weeks of gestation
Live-birth rate
Time frame: The live birth rate is assessed at the time of birth, including both full-term and preterm live births.
Implantation rate
Time frame: Between 3 and 5 weeks after embryo transfer.
Endometrial Thickness
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Uterine Artery Doppler Indices (e.g., PI, RI)
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Endometrial Vascularization
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histogram Indices (Blood flow velocities)
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histogram Indices (cell sizes)
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Histological Dating of Endometrium
Time frame: The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 30859080Mehrafza 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.
- Background: PubMed 24269084Coughlan 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.
- Background: PubMed 17674185Rinehart 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.
- Background: PubMed 25785127Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael SS Elbanna, Consultant principal investigator
Wael Elbanna Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granulocyte Colony Stimulating Factor, Platelet Rich Plasma Arm and Saline in people with Infertility and Frozen Embryo Transfer (FET), run by Wael Elbanna Clinic at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical pregnancy rate (time frame: 6 to 8 weeks of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945812, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.