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Effect of GCSF in treatment of women infertility

comparison of the effect of Granulocyte Colony Stimulating Factor (G-CSF) and Growth Hormone(GH) on improvement outcome of pregnancy and fetus quality ,in women with diminished ovarian reserve(POR) on artificial Reproductive Technology (ART), a Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110509006420N29
Enrollment
92
Registered
2025-05-16
Start date
2025-05-04
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor responders in IVF. Female infertility, unspecified

Interventions

Intervention 1: Intervention group: The group receiving G-CSF( 125 mcg in the day 2,7,and triger day of cycle), starting from the second day of the menstrual cycle, ultrasound will be performed and

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women referring to the Yazd Reproductive Sciences Institute Women with diminished ovarian reserve based on POSEIDON group 3 and 4 criteria: antral follicle count (AFC) less than 5 and AMH less than 1.2 ng/mL. Age between 20 and 45 Women undergoing controlled ovarian stimulation (COS) with an antagonist protocol

Exclusion criteria

Exclusion criteria: History of blood, autoimmune, coagulation, endocrine, kidney, or heart diseases that would contraindicate pregnancy. genital anomaly Hydrosalpanx uterus fibroid or ovarian mass drug addiction sever male infertility (sever oligospermy or azospermy) coagulation disorder and use of anticoagulant drugs failure to fallow up the patient Having a recent infectious disease (AIDS, hepatitis, etc.) or a severe infection of the genitourinary system or STD A woman or man suffering from a severe mental illness or genetic disease that makes it impossible for them to reproduce according to the Maternal and Child Health Act. Contraindications to G-CSF use (sickle cell anemia, pneumonia, upper respiratory tract infection, chronic neutropenia, idiopathic autoimmune thrombocytopenia) Use of G-CSF or GH in the last three months adenomyosis Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Number of eggs retrieved from ovary. Timepoint: Immediately after egg retrieval in each individual. Method of measurement: Microscopic count by an embryologist.;Quality of harvested oocytes. Timepoint: At least three hours after egg retrieval. Method of measurement: Oocyte morphology assessment by an embryologist under a microscope.;Number of formed embryo. Timepoint: 16-18 hours after IVf or ICSI. Method of measurement: Microscopic examination and counting by an embryologist.;Quality of formed embryo. Timepoint: 2-5 days after formed embryos. Method of measurement: Microscopic examination by embryologist based on Gardner score.;Number of 2PN embryos. Timepoint: 24 after formed embryos. Method of measurement: Microscopic examination and counting of 2PN embryos by an embryologist.;Number of chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Serum BHCG level measurement.;Number of clinical pregnancy. Timepoint: at least 4 week after embryo transfer. Method of measurement: Fetal heart assessment in vaginal or abdominal ultrasound.

Secondary

MeasureTime frame
Amount of gonadotropin received during the induction ovulation cycle. Timepoint: From the start day to the end day of the ovulation stimulation protocol. Method of measurement: Total amount of gonadotropin received from the start of the ovarian stimulation cycle until the trigger day for each individual.;Number of days of gonadotropin administration. Timepoint: From the day of receiving gonadotropin to the end day of the trigger. Method of measurement: Total number of days of gonadotropin administration for each person.;Blood Estradiol level. Timepoint: Trigger Day (DAY of receiving HCG). Method of measurement: Blood sampling in picograms per milliliter.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmaryam eftekhar

Yazd University of Medical Sciences

eftekhar@ssu.ac.ir+98 35 3824 7085

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026