The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF

Comparative Study Between Granulocyte Colony Stimulating Factor and Human Chorionic Gonadotropin in Patients With History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection (at Ovum Pick up Day)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04604054

Enrollment

100

Registered

2020-10-27

Start date

2020-10-30

Completion date

2021-01-10

Last updated

2020-10-27

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

Conditions

Fertility Disorders

Brief summary

One hundred patients who suffered from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were allocated in the study. On ovum pick-up day, 50 of them were intrauterine injected with granulocyte colony-stimulating factor (G-CSF) and the other 50 were injected with intrauterine Human Chorionic Gonadotropins (HCG). The clinical pregnancy rate was evaluated as a primary outcome and ultrasound imaging of the gestational sac was evaluated as a secondary outcome

Detailed description

One hundred patients suffering from recurrent implantation failure in intracytoplasmic sperm injection (ICSI) were included in the study. The patients were randomly allocated into two groups. The intervention group consisted of 50 patients who received intrauterine injected with granulocyte colony-stimulating factor (G-CSF). The other group (the control group) consisted of 50 patients and injected with intrauterine Human Chorionic Gonadotropins (HCG). Both groups received the interventions at ovum pick-up day. The main outcome was the clinical pregnancy rate which has been evaluated after 2 weeks of the positive pregnancy test. The secondary outcome was an ultrasound image of the gestational sac after 6 weeks of pregnancy.

Interventions

DRUGGranulocyte Colony Stimulated Factor

GCSF was intrauterine injected once at ovum pick up day

DRUGHuman Chorionic Gonadotropins

500 IU of HCG was injected intrauterine once at ovum pick up day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Females suffering from recurrent implantation failure and undergoing ICSI

Exclusion criteria

* presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders

Design outcomes

Primary

Measure	Time frame	Description
clinical pregnancy rate	after 14 days from positive pregnancy test	number of pregnancies that is confirmed by both high levels of hCG (the pregnancy hormone) and ultrasound confirmation of a gestational sac or heartbeat (fetal pole)

Secondary

Measure	Time frame	Description
ultrasound image of Gestational sac	6 weeks of pregnancy	The gestational sac (GS) is the first sign of early pregnancy on ultrasound

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026