InfertilityNCT03824340
Intracytoplasmic Sperm Injection Preparation in Infertile Women
A study testing Doxycycline before ICSI in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Infertility is a common gynecological problem is women Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Doxycycline before ICSI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2019to 1 Jan 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who have infertility with age between 20 -42 years
Who cannot join
- women who has ovarian or endometrial factor of infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility
Infertility is a common gynecological problem is women
Read the detailed description
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem
- Conditions
- Infertility
- Being tested
- Doxycycline 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.
Doxycycline before ICSIDrug
Also called Medical treatment with Doxycycline
Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline before ICSI | Active comparator | extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI Receives: Drug: Doxycycline before ICSI |
| control group | No intervention | control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) 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 successful ICSI
The number of women who will get pregnant after ICSI with extra treatment
Measured: within 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start30 Jan 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion1 Jan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824340
- Sponsor's protocol ID
- ICSI preparation
- Status last verified
- Aug 2019
- First submitted
- 25 Jan 2019
- Last updated
- 6 Aug 2019
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03824340
- Acronym / sponsor ID
- ICSI preparation
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 31 Jan 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.
Infertility is a common gynecological problem is women
Detailed description
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Doxycycline before ICSI | Active comparator | Drug: Doxycycline before ICSIextra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI |
| control group | No intervention | –control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who have infertility with age between 20 -42 years
Key exclusion criteria (1 listed)
- women who has ovarian or endometrial 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 |
|---|---|---|
| Doxycycline before ICSIAlso: Medical treatment with DoxycyclineExtra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process | Drug | Doxycycline before ICSI |
Primary outcome
the number of women who will have successful ICSI
Time frame: within 4 months
The number of women who will get pregnant after ICSI with extra treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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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 principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline before ICSI in people with Infertility, run by Aljazeera Hospital at 1 site 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Mahmoud Alalfy, PhD (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of women who will have successful ICSI (time frame: within 4 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 6 Aug 2019.