Fertility DisordersNCT04606082
Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor in Increasing Pregnancy Rate in ICSI
A study testing Granulocyte Colony Stimulated Factor and Human Chorionic Gonadotropins in people with Fertility Disorders, run by Al-Azhar University.
Trial summary
Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmic Sperm Injection
Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.
Read the detailed description
Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.
- 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, Neupogen, Granix and Zarxio
GCSF was intrauterine injected once at ovum pick up day
Human Chorionic GonadotropinsDrug
Also called HCG, Novarel, and Pregnyl
500 IU of HCG was injected intrauterine once at ovum pick up day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Granulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day Receives: Drug: Granulocyte Colony Stimulated Factor |
| Group 2 | Active comparator | 500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day 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
Clinical pregnancy was evaluated by high HCG levels
Measured: after 14 days from positive pregnancy test
Secondary outcomes (1)
Gestational sac imaging
ultrasound imaging of Gestational sac after 6 weeks of pregnancy
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 posted28 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
- 200 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
- Investigators
- Elsayed Eldesouky, Principal investigator, Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606082
- Sponsor's protocol ID
- Gyne_415
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 28 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 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT04606082
- Acronym / sponsor ID
- Gyne_415
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 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
- 28 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.
Intrauterine Granulocyte colony stimulating factor (GCSF) was compared with intrauterine Human Chorionic Gonadotropin (HCG) in increasing clinical pregnancy rate as a primary outcome and ultrasound imaging of gestational sac as a secondary outcome.
Detailed description
Two hundred females with history of recurrent implantation failure and undergoing Intracytoplasmic Sprem injection (ICSI) were randomized into two groups; the first group (100 patients) received intrauterine Granulocyte colony stimulating factor (GCSF) and the second group (100) received intrauterine Human Chorionic Gonadotropin (HCG) at ovum pick up day. The clinical pregnancy rate was evaluated as a primary outcome after 14 days and ultrasound imaging of gestational sac was evaluated as a secondary outcome after 6 weeks.
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 FactorGranulocyte Colony Stimulated Factor was intrauterine injected once at ovum pick up day |
| Group 2 | Active comparator | Drug: Human Chorionic Gonadotropins500 IU Human Chorionic Gonadotropins was injected intrauterine once at ovum pick up day |
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: GCSF, Neupogen, Granix and ZarxioGCSF was intrauterine injected once at ovum pick up day | Drug | Group 1 |
| Human Chorionic GonadotropinsAlso: HCG, Novarel, and Pregnyl500 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
Clinical pregnancy was evaluated by high HCG levels
1 secondary outcome
Gestational sac imaging
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 28 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.
Elsayed Eldesouky principal investigator
Assistant professor of obstetrics and gynecology faculty of medicine Alazhar university Cairo
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 28 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?
Contact Elsayed Eldesouky (00201092934978, elsayedeldesouky@yahoo.com), or a site near the patient. 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 28 Oct 2020.