NCT07724405

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
14mo left

Started Jul 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Oct 2027

Study Start

First participant enrolled

July 10, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 14, 2026

Last Update Submit

July 20, 2026

Conditions

Recurrent Pregnancy LossRecurrent Miscarriages

Keywords

T helper cellsImmunological causes of miscarriagemiscarriagepregnancy lossgranulocyte-colony stimulating factorG-CSF

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy confirmation by transvaginal ultrasound at 16 weeks' gestation.

    From enrollment to 16 weeks gestation

Secondary Outcomes (6)

  • Live birth rate

    From enrollment to approximately 40 weeks' gestation.

  • Ongoing Pregnancy Rate

    From 16 weeks to 34 weeks gestation.

  • Early Pregnancy Loss rate

    From FET (Fetal Embryo Transfer) to 12 weeks gestation

  • Rate of Adverse pregnancy outcomes (APOs)

    From enrollment to approximately 40 weeks gestation

  • Rate of Adverse events

    From enrollment up to approximately 40 weeks gestation (delivery)

  • +1 more secondary outcomes

Study Arms (2)

Recombinant G-CSF 130 mcg SC

EXPERIMENTAL

Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation

Drug: Recombinant G-CSF

Placebo Control: Placebo SC

PLACEBO COMPARATOR

Subcutaneous injection of placebo daily from embryo transfer until 12 weeks' gestation

Drug: Placebo control

Interventions

Placebo controlDRUG

Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation

Placebo Control: Placebo SC
Recombinant G-CSFDRUG

Subcutaneous injection of Recombinant G-CSF daily from embryo transfer until 12 weeks' gestation

Recombinant G-CSF 130 mcg SC

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological females only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-44 years
  • ≥2 unexplained pregnancy losses
  • Undergoing IVF with PGT-A tested embryos
  • BMI 19-35 kg/m² 6.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fakih IVF Fertility Centre LLC

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (12)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 19617208BACKGROUND

  • Eftekhar 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 24424357BACKGROUND

  • Wurfel 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.

    PMID: 25740726BACKGROUND

  • Kwak-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.

    PMID: 24661472BACKGROUND

  • Saito 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.

    PMID: 20455873BACKGROUND

  • American Society for Reproductive Medicine (ASRM). Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2023;120(6):1255-1271.

    BACKGROUND

  • 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.

    PMID: 36873081BACKGROUND

MeSH Terms

Conditions

Abortion, HabitualAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Dr. Lamiya Mohiyiddeen, MD, FRCOG

CONTACT

+971543676002lamiya.mohiyiddeen@fakihivf.com

Fatma Bathawab, PhD

CONTACT

+971585707393fatma.bathawab@fakihivf.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This is double blind randomized controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled, multi-centre trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director, Research Ethics Committee Chair

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 24, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

October 10, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations

AE(1)