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

NCT04604054 | Unknown

• 1 other identifier: 000000415
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  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)

  after 14 days from positive pregnancy test

Secondary Outcomes (1)

• ultrasound image of Gestational sac

  6 weeks of pregnancy

Study Arms (2)

Group 1

EXPERIMENTAL

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment.

Drug: Granulocyte Colony Stimulated Factor

Group 2

ACTIVE COMPARATOR

Females With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment.

Drug: Human Chorionic Gonadotropins

Interventions

Granulocyte Colony Stimulated Factor DRUG

GCSF was intrauterine injected once at ovum pick up day

Also known as: GCSF

Group 1

Human Chorionic Gonadotropins DRUG

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

Also known as: HCG

Group 2

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females suffering from recurrent implantation failure and undergoing ICSI

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 27, 2020
• Study Start: October 30, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: October 27, 2020

Record last verified: 2020-10