Fertility DisordersNCT04604054
The Effect of Granulocyte Colony Stimulating Factor Versus Human Chorionic Gonadotropin in Females With a History of RIF
A study testing Granulocyte Colony Stimulated Factor and Human Chorionic Gonadotropins in people with Fertility Disorders, run by Al-Azhar University.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Granulocyte Colony Stimulated Factor and Human Chorionic Gonadotropins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2020to 10 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females suffering from recurrent implantation failure and undergoing ICSI
Who cannot join
- presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
About this study
Official title: 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)
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
Read the 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.
- Conditions
- Fertility Disorders
- Being tested
- Granulocyte Colony Stimulated Factor, Human Chorionic Gonadotropins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony Stimulated FactorDrug
Also called GCSF
GCSF was intrauterine injected once at ovum pick up day
Human Chorionic GonadotropinsDrug
Also called HCG
500 IU of HCG was injected intrauterine once at ovum pick up day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Human Chorionic Gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after 14 days from positive pregnancy test
Secondary outcomes (1)
ultrasound image of Gestational sac
The gestational sac (GS) is the first sign of early pregnancy on ultrasound
Measured: 6 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 Oct 2020 (estimated)
- Primary completion10 Jan 2021 (estimated)
- Study completion10 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Eldesouky, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604054
- Sponsor's protocol ID
- 000000415
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04604054
- Acronym / sponsor ID
- 000000415
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 10 Jan 2021 (estimated)
- First posted
- 27 Oct 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Granulocyte Colony Stimulated FactorFemales With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Granulocyte Colony Stimulating Factor as a treatment. |
| Group 2 | Active comparator | Drug: Human Chorionic GonadotropinsFemales With a History of Recurrent Implantation Failure in Intra Cytoplasmic Sperm Injection will receive Human Chorionic Gonadotropin as a treatment. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females suffering from recurrent implantation failure and undergoing ICSI
Key exclusion criteria (1 listed)
- presence of comorbidity as diabetes, hypertension, heart diseases, or endocrine disorders
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 |
|---|---|---|
| Granulocyte Colony Stimulated FactorAlso: GCSFGCSF was intrauterine injected once at ovum pick up day | Drug | Group 1 |
| Human Chorionic GonadotropinsAlso: HCG500 IU of HCG was injected intrauterine once at ovum pick up day | Drug | Group 2 |
Primary outcome
clinical pregnancy rate
Time frame: 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)
1 secondary outcome
ultrasound image of Gestational sac
Time frame: 6 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Granulocyte Colony Stimulated Factor and Human Chorionic Gonadotropins in people with Fertility Disorders, run by Al-Azhar University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: after 14 days from positive pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.