InfertilityNCT04184167
Role of Intermittent Fasting Before ICSI
A study testing intermittent fasting 4 months before ICSI in people with Infertility, run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
intermittent fasting could have a role in infertility Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- intermittent fasting 4 months before ICSI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Dec 2019to 1 Oct 2020
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with infertility
Who cannot join
- ovarian factor or uterine factor of infertility
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Algazeerah and helwan university
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
- Not yet recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection
intermittent fasting could have a role in infertility
Read the detailed description
intermittent fasting could have a role in infertility and could adjust the body weight before ICSI
- Conditions
- Infertility
- Being tested
- intermittent fasting 4 months before ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fasting 4 months before ICSIOther
women will start intermittent fasting before starting ICSI by 4 months
| Study group | Role | What they receive |
|---|---|---|
| intermittent fasting | Active comparator | intermittent fasting before ICSI Receives: Other: intermittent fasting 4 months before ICSI |
| No intermittent fasting | Placebo comparator | Usual diet Receives: Other: intermittent fasting 4 months before ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of women who will have positive pregnancy test after ICSI
The women who will get pregnant after ICSI with positive pregnancy test
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start2 Dec 2019
- Primary completion2 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184167
- Sponsor's protocol ID
- Role of intermittent fasting
- Status last verified
- Jan 2020
- First submitted
- 29 Nov 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT04184167
- Acronym / sponsor ID
- Role of intermittent fasting
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 2 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 3 Dec 2019 (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.
intermittent fasting could have a role in infertility
Detailed description
intermittent fasting could have a role in infertility and could adjust the body weight before ICSI
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent fasting | Active comparator | Other: intermittent fasting 4 months before ICSIintermittent fasting before ICSI |
| No intermittent fasting | Placebo comparator | Other: intermittent fasting 4 months before ICSIUsual diet |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with infertility
Key exclusion criteria (1 listed)
- ovarian factor or uterine factor of infertility
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 |
|---|---|---|
| intermittent fasting 4 months before ICSIwomen will start intermittent fasting before starting ICSI by 4 months | Other | No intermittent fasting, intermittent fasting |
Primary outcome
the number of women who will have positive pregnancy test after ICSI
Time frame: within 6 months
The women who will get pregnant after ICSI with positive pregnancy test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
Mahmoud Alalfy, PhD study chair
Algezeera hospitaland National Research Centre ,Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent fasting 4 months before ICSI in people with Infertility, run by Aljazeera Hospital at 2 sites in Egypt.
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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will have positive pregnancy test after ICSI (time frame: within 6 months). 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 Jan 2020.