Recurrent Pregnancy LossPhase 2GEMNCT07724405
Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage
A Phase 2 study testing Recombinant G-CSF in people with Recurrent Pregnancy Loss and Recurrent Miscarriages, run by Fakih IVF Fertility Center at 1 site in United Arab Emirates.
Trial summary
Recurrent pregnancy loss (RPL), commonly referred to as recurrent miscarriage, affects approximately 1-2% of couples attempting to conceive. In nearly half of these cases, no definitive cause can be identified despite thorough clinical evaluation. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Recurrent Miscarriages
- What is being tested?
- Recombinant G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Jul 2026to 10 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-44 years
- ≥2 unexplained pregnancy losses
- Undergoing IVF with PGT-A tested embryos
- BMI 19-35 kg/m² 6.
Who cannot join
- Parental karyotype abnormalities
- Correctable uterine abnormalities
- Systemic autoimmune disease / thrombophilia
- Uncontrolled systemic illness (e.g. diabetes, infection)
- Previous G-CSF therapy
- Hypersensitivity to rhG-CSF or E. coli proteins
- HIV, malignancy within 5 years, or severe cardiovascular/respiratory history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Fakih IVF Fertility Centre LLC
Abu Dhabi
Dr. Lamiya Mohiyiddeen, MD, FRCOG, +971543676002, lamiya.mohiyiddeen@fakihivf.com
Fatma Bathawab, PhD, +971585707393, fatma.bathawab@fakihivf.com
About this study
Official title: A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage After IVF With PGT-A Screened Euploid Embryo Transfer
Recurrent pregnancy loss (RPL), commonly referred to as recurrent miscarriage, affects approximately 1-2% of couples attempting to conceive. In nearly half of these cases, no definitive cause can be identified despite thorough clinical evaluation. A circumstance that is both distressing and disorienting for affected families, particularly in settings such as the United Arab Emirates (UAE), where childbearing carries significant personal and cultural weight.
One leading hypothesis is that the underlying problem may not lie with the embryo itself, but with the way the mother's immune system responds to a developing pregnancy. Under normal physiological conditions, the maternal body must establish immune tolerance toward an embryo that is genetically half-foreign in origin. In some women, this tolerance mechanism may be impaired, reducing the likelihood that a pregnancy will successfully implant and progress.
Read more
This study will evaluate whether granulocyte colony-stimulating factor (G-CSF) a naturally occurring substance that normally stimulates the production of immune cells can help address this issue by modulating an overactive immune response and enhancing the uterine environment's capacity to support pregnancy. Notably, the study will enroll only women whose embryos have undergone genetic testing and been confirmed to be chromosomally normal. This eliminates embryo quality as a contributing factor to pregnancy loss and allows for a clearer assessment of whether G-CSF itself influences outcomes.
Earlier small-scale studies, including preliminary work conducted at our own centre, have shown encouraging results. This new trial builds on that foundation by enrolling a larger cohort, comparing G-CSF against a placebo (an inactive comparison treatment), and evaluating a simpler route of administration; subcutaneous injection, rather than direct infusion into the uterus. Together, these design features aim to provide the most reliable evidence to date on whether this treatment can meaningfully help couples affected by unexplained recurrent pregnancy loss.
Read the detailed description
Recurrent pregnancy loss (RPL) defined as two or more consecutive miscarriages before 20 weeks' gestation affects 1-2% of couples worldwide and remains one of the most distressing, poorly resolved conditions in reproductive medicine. In nearly half of cases, no definitive cause is identified. This burden is especially pronounced in the UAE and wider GCC region, where delayed childbearing and the strong sociocultural weight placed on fertility amplify the psychological, marital, and financial toll of unexplained RPL.
Despite decades of research, treatment remains largely empirical. Immune dysregulation is increasingly implicated as a central mechanism, with proposed pathways including aberrant natural killer (NK) cell activation, impaired regulatory T-cell expansion, inadequate decidualization, and an unfavorable Th1/Th17 cytokine profile, collectively compromising endometrial receptivity and embryo survival. However, most supporting studies have been small, uncontrolled, and unable to distinguish maternal immunological causes from embryo genetic abnormalities, leaving clinicians with few evidence-based options.
Granulocyte colony-stimulating factor (G-CSF), a hematopoietic cytokine with immunomodulatory and endometrial effects, has emerged as a promising candidate. Preclinical and early clinical data suggest it enhances endometrial proliferation and vascularization, supports folliculogenesis and oocyte competence, and promotes immune tolerance by expanding regulatory T-cells while reducing NK cell cytotoxicity. Small trials in both recurrent implantation failure and RPL populations have reported benefits in implantation and live birth rates, though results have been inconsistent - largely due to the same methodological limitations noted above, plus a failure to control for embryo aneuploidy as a confounder.
Our own retrospective pilot study of 19 patients receiving intrauterine G-CSF supports this rationale: 70.5% achieved a positive β-hCG, 66.7% progressed to ongoing pregnancy, and no adverse effects were observed. These findings demonstrate both feasibility and preliminary efficacy at our centre. However, intrauterine infusion is invasive, costly, and less patient-friendly; existing literature suggests subcutaneous administration may achieve comparable efficacy with greater convenience, but this route has not yet been evaluated in this specific population.
The GEM Trial is designed to resolve these open questions directly. By enrolling women with unexplained RPL undergoing IVF with preimplantation genetic testing for aneuploidy (PGT-A), the trial eliminates embryo chromosomal abnormality as a confounder, enabling a precise, mechanistically targeted test of the immunological hypothesis. It will be the first placebo-controlled, genetically controlled trial of G-CSF in this population, and the first to formally assess subcutaneous delivery.
If successful, the GEM Trial could establish a new standard of care for unexplained RPL offering a more convenient, evidence-based treatment option to thousands of couples and positioning the UAE as a global leader in reproductive immunology research.
- Conditions
- Recurrent Pregnancy Loss, Recurrent Miscarriages
- Being tested
- Placebo control, Recombinant G-CSF
- Keywords
- T helper cells, Immunological causes of miscarriage, miscarriage, pregnancy loss, granulocyte-colony stimulating factor, G-CSF
- Medical subject headings
- Abortion, Habitual, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo controlDrug
Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation
Recombinant G-CSFDrug
Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation
| Study group | Role | What they receive |
|---|---|---|
| Recombinant G-CSF 130 mcg SC | Experimental | Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation Receives: Drug: Recombinant G-CSF |
| Placebo Control: Placebo SC | Placebo comparator | Subcutaneous injection of placebo daily from embryo transfer until 12 weeks' gestation Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy confirmation by transvaginal ultrasound at 16 weeks' gestation.
Measured: From enrollment to 16 weeks gestation
Secondary outcomes (6)
Live birth rate
Measured: From enrollment to approximately 40 weeks' gestation.
Ongoing Pregnancy Rate
16 - 34 weeks gestation by serial ultrasound.
Measured: From 16 weeks to 34 weeks gestation.
Early Pregnancy Loss rate
Pregnancy loss confirmed by a transvaginal ultrasound.
Measured: From FET (Fetal Embryo Transfer) to 12 weeks gestation
Rate of Adverse pregnancy outcomes (APOs)
Rate of Miscarriage, stillbirth, neonatal outcomes (birth weight, NICU admission, congenital anomalies) and maternal outcomes assessed using several methods including transvaginal ultrasound and clinical assessment.
Measured: From enrollment to approximately 40 weeks gestation
Rate of Adverse events
Safety data including pregnancy related, fetal or maternal adverse events e.g. infections, cytopenias, hypersensitivity etc.
Measured: From enrollment up to approximately 40 weeks gestation (delivery)
Rate of immunogenicity
Anti-drug antibody (ADA) formation (serology in subset).
Measured: From enrollment to up to approximately 40 weeks gestation (delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Jul 2026
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, multi-centre trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakih IVF Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiya Mohiyiddeen, Fakih IVF Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724405
- Sponsor's protocol ID
- FAKIH-2025-10
- Other IDs
- DOH/ADHRTC/2026/34566666666666
- Acronym
- GEM
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Impact of Intrauterine Infusion vs Subcutaneous G-CSF Injection on Endometrial Immunomodulation and Angiogenesis in Infertile Women undergoing IUI; Zainab AbdulQaderMahmood, LubnaAmerAl-Anbari, ManalTahaAl-Obaidi, 2025 Trends in Immunotherapy|Volume 09|Issue 03
P-347 A comparative RCT of Intrauterine-GCSF versus Subcutaneous-GCSF in Thin Endometrium in IVF-ICSI Cycles, P C Jindal, M Singh, Human Reproduction, Volume 36, Issue Supplement_1, July 2021, deab130.346
GCSF in patients with thin endometrium-subcutaneous or intrauterine?, Shilpa Singal, R.K. Sharma, Nupur Ahuja, Fertility Science and research 10.4103/2394-4285.288714
Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
PubMed 19617208Eftekhar M, Miraj S, Najafian A. Efficacy of intrauterine infusion of G-CSF in infertile women: a systematic review and meta-analysis. Int J Reprod Biomed. 2016;14(9):557-566.
Santjohanser C, Hosseini M, Schönleber J, et al. G-CSF in patients with recurrent miscarriage and recurrent implantation failure: a prospective, randomized, double-blind, placebo-controlled trial. Hum Reprod. 2013;28(1):72-79.
Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.
PubMed 24424357Wurfel W. Treatment with granulocyte colony-stimulating factor in patients with repetitive implantation failures and/or recurrent spontaneous abortions. J Reprod Immunol. 2015 Apr;108:123-35. doi: 10.1016/j.jri.2015.01.010. Epub 2015 Feb 21.
PubMed 25740726Kwak-Kim J, Bao S, Lee SK, Kim JW, Gilman-Sachs A. Immunological modes of pregnancy loss: inflammation, immune effectors, and stress. Am J Reprod Immunol. 2014 Aug;72(2):129-40. doi: 10.1111/aji.12234. Epub 2014 Mar 24.
PubMed 24661472Saito S, Nakashima A, Shima T, Ito M. Th1/Th2/Th17 and regulatory T-cell paradigm in pregnancy. Am J Reprod Immunol. 2010 Jun;63(6):601-10. doi: 10.1111/j.1600-0897.2010.00852.x. Epub 2010 Apr 23.
PubMed 20455873American Society for Reproductive Medicine (ASRM). Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2023;120(6):1255-1271.
ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
PubMed 36873081
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Recombinant Human G-CSF in Women With Unexplained Recurrent Miscarriage After IVF With PGT-A Screened Euploid Embryo Transfer
- ClinicalTrials.gov ID
- NCT07724405
- Acronym / sponsor ID
- GEM / FAKIH-2025-10
- Conditions
- Recurrent Pregnancy Loss, Recurrent Miscarriages
- Keywords
- T helper cells, Immunological causes of miscarriage, miscarriage, pregnancy loss, granulocyte-colony stimulating factor, G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fakih IVF Fertility CenterUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
Recurrent pregnancy loss (RPL), commonly referred to as recurrent miscarriage, affects approximately 1-2% of couples attempting to conceive. In nearly half of these cases, no definitive cause can be identified despite thorough clinical evaluation. A circumstance that is both distressing and disorienting for affected families, particularly in settings such as the United Arab Emirates (UAE), where childbearing carries significant personal and cultural weight.
One leading hypothesis is that the underlying problem may not lie with the embryo itself, but with the way the mother's immune system responds to a developing pregnancy. Under normal physiological conditions, the maternal body must establish immune tolerance toward an embryo that is genetically half-foreign in origin. In some women, this tolerance mechanism may be impaired, reducing the likelihood that a pregnancy will successfully implant and progress.
This study will evaluate whether granulocyte colony-stimulating factor (G-CSF) a naturally occurring substance that normally stimulates the production of immune cells can help address this issue by modulating an overactive immune response and enhancing the uterine environment's capacity to support pregnancy. Notably, the study will enroll only women whose embryos have undergone genetic testing and been confirmed to be chromosomally normal. This eliminates embryo quality as a contributing factor to pregnancy loss and allows for a clearer assessment of whether G-CSF itself influences outcomes.
Earlier small-scale studies, including preliminary work conducted at our own centre, have shown encouraging results. This new trial builds on that foundation by enrolling a larger cohort, comparing G-CSF against a placebo (an inactive comparison treatment), and evaluating a simpler route of administration; subcutaneous injection, rather than direct infusion into the uterus. Together, these design features aim to provide the most reliable evidence to date on whether this treatment can meaningfully help couples affected by unexplained recurrent pregnancy loss.
Detailed description
Recurrent pregnancy loss (RPL) defined as two or more consecutive miscarriages before 20 weeks' gestation affects 1-2% of couples worldwide and remains one of the most distressing, poorly resolved conditions in reproductive medicine. In nearly half of cases, no definitive cause is identified. This burden is especially pronounced in the UAE and wider GCC region, where delayed childbearing and the strong sociocultural weight placed on fertility amplify the psychological, marital, and financial toll of unexplained RPL.
Despite decades of research, treatment remains largely empirical. Immune dysregulation is increasingly implicated as a central mechanism, with proposed pathways including aberrant natural killer (NK) cell activation, impaired regulatory T-cell expansion, inadequate decidualization, and an unfavorable Th1/Th17 cytokine profile, collectively compromising endometrial receptivity and embryo survival. However, most supporting studies have been small, uncontrolled, and unable to distinguish maternal immunological causes from embryo genetic abnormalities, leaving clinicians with few evidence-based options.
Granulocyte colony-stimulating factor (G-CSF), a hematopoietic cytokine with immunomodulatory and endometrial effects, has emerged as a promising candidate. Preclinical and early clinical data suggest it enhances endometrial proliferation and vascularization, supports folliculogenesis and oocyte competence, and promotes immune tolerance by expanding regulatory T-cells while reducing NK cell cytotoxicity. Small trials in both recurrent implantation failure and RPL populations have reported benefits in implantation and live birth rates, though results have been inconsistent - largely due to the same methodological limitations noted above, plus a failure to control for embryo aneuploidy as a confounder.
Our own retrospective pilot study of 19 patients receiving intrauterine G-CSF supports this rationale: 70.5% achieved a positive β-hCG, 66.7% progressed to ongoing pregnancy, and no adverse effects were observed. These findings demonstrate both feasibility and preliminary efficacy at our centre. However, intrauterine infusion is invasive, costly, and less patient-friendly; existing literature suggests subcutaneous administration may achieve comparable efficacy with greater convenience, but this route has not yet been evaluated in this specific population.
The GEM Trial is designed to resolve these open questions directly. By enrolling women with unexplained RPL undergoing IVF with preimplantation genetic testing for aneuploidy (PGT-A), the trial eliminates embryo chromosomal abnormality as a confounder, enabling a precise, mechanistically targeted test of the immunological hypothesis. It will be the first placebo-controlled, genetically controlled trial of G-CSF in this population, and the first to formally assess subcutaneous delivery.
If successful, the GEM Trial could establish a new standard of care for unexplained RPL offering a more convenient, evidence-based treatment option to thousands of couples and positioning the UAE as a global leader in reproductive immunology research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, multi-centre trial
| Arm | Type | Receives |
|---|---|---|
| Recombinant G-CSF 130 mcg SC | Experimental | Drug: Recombinant G-CSFSubcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation |
| Placebo Control: Placebo SC | Placebo comparator | Drug: Placebo controlSubcutaneous injection of placebo daily from embryo transfer until 12 weeks' gestation |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-44 years
- ≥2 unexplained pregnancy losses
- Undergoing IVF with PGT-A tested embryos
- BMI 19-35 kg/m² 6.
Key exclusion criteria (7 listed)
- Parental karyotype abnormalities
- Correctable uterine abnormalities
- Systemic autoimmune disease / thrombophilia
- Uncontrolled systemic illness (e.g. diabetes, infection)
- Previous G-CSF therapy
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 |
|---|---|---|
| Placebo controlSubcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation | Drug | Placebo Control: Placebo SC |
| Recombinant G-CSFSubcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation | Drug | Recombinant G-CSF 130 mcg SC |
Primary outcome
Clinical pregnancy rate
Time frame: From enrollment to 16 weeks gestation
Clinical pregnancy confirmation by transvaginal ultrasound at 16 weeks' gestation.
6 secondary outcomes
Live birth rate
Time frame: From enrollment to approximately 40 weeks' gestation.
Ongoing Pregnancy Rate
Time frame: From 16 weeks to 34 weeks gestation.
Early Pregnancy Loss rate
Time frame: From FET (Fetal Embryo Transfer) to 12 weeks gestation
Rate of Adverse pregnancy outcomes (APOs)
Time frame: From enrollment to approximately 40 weeks gestation
Rate of Adverse events
Time frame: From enrollment up to approximately 40 weeks gestation (delivery)
Rate of immunogenicity
Time frame: From enrollment to up to approximately 40 weeks gestation (delivery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- BackgroundImpact of Intrauterine Infusion vs Subcutaneous G-CSF Injection on Endometrial Immunomodulation and Angiogenesis in Infertile Women undergoing IUI; Zainab AbdulQaderMahmood, LubnaAmerAl-Anbari, ManalTahaAl-Obaidi, 2025 Trends in Immunotherapy|Volume 09|Issue 03
- BackgroundP-347 A comparative RCT of Intrauterine-GCSF versus Subcutaneous-GCSF in Thin Endometrium in IVF-ICSI Cycles, P C Jindal, M Singh, Human Reproduction, Volume 36, Issue Supplement_1, July 2021, deab130.346
- BackgroundGCSF in patients with thin endometrium-subcutaneous or intrauterine?, Shilpa Singal, R.K. Sharma, Nupur Ahuja, Fertility Science and research 10.4103/2394-4285.288714
- Background: PubMed 19617208Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
- BackgroundEftekhar M, Miraj S, Najafian A. Efficacy of intrauterine infusion of G-CSF in infertile women: a systematic review and meta-analysis. Int J Reprod Biomed. 2016;14(9):557-566.
- BackgroundSantjohanser C, Hosseini M, Schönleber J, et al. G-CSF in patients with recurrent miscarriage and recurrent implantation failure: a prospective, randomized, double-blind, placebo-controlled trial. Hum Reprod. 2013;28(1):72-79.
- Background: PubMed 24424357Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.
- Background: PubMed 25740726Wurfel W. Treatment with granulocyte colony-stimulating factor in patients with repetitive implantation failures and/or recurrent spontaneous abortions. J Reprod Immunol. 2015 Apr;108:123-35. doi: 10.1016/j.jri.2015.01.010. Epub 2015 Feb 21.
- Background: PubMed 24661472Kwak-Kim J, Bao S, Lee SK, Kim JW, Gilman-Sachs A. Immunological modes of pregnancy loss: inflammation, immune effectors, and stress. Am J Reprod Immunol. 2014 Aug;72(2):129-40. doi: 10.1111/aji.12234. Epub 2014 Mar 24.
- Background: PubMed 20455873Saito S, Nakashima A, Shima T, Ito M. Th1/Th2/Th17 and regulatory T-cell paradigm in pregnancy. Am J Reprod Immunol. 2010 Jun;63(6):601-10. doi: 10.1111/j.1600-0897.2010.00852.x. Epub 2010 Apr 23.
- BackgroundAmerican Society for Reproductive Medicine (ASRM). Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2023;120(6):1255-1271.
- Background: PubMed 36873081ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant G-CSF in people with Recurrent Pregnancy Loss and Recurrent Miscarriages, run by Fakih IVF Fertility Center at 1 site in United Arab Emirates.
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 4 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. 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 United Arab Emirates. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lamiya Mohiyiddeen, MD, FRCOG (+971543676002, lamiya.mohiyiddeen@fakihivf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: From enrollment to 16 weeks gestation). 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 NCT07724405, which also lists 12 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 24 Jul 2026.