IVFNCT04939376
Uterine Lesions and Their Association to Invitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI) Outcome
An observational study of IVF, run by Assiut University.
Trial summary
1. To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle. 2. To establish a score for prediction of IVF/ICSI cycle success . Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- IVF
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Apr 2024
- Phase
- Observational
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between 18 and 38 years old. * An indication for IVF/ICSI.. * Women with BMI between 18.5 : 29.9 .
Who may be able to join
- Women between 18 and 38 years old.
- An indication for IVF/ICSI..
- Women with BMI between 18.5 : 29.9 .
- Women with normal antimullerian hormone(AMH), antral follicle count(AFC) (good responders).
Who cannot join
- Refusal to join the study.
- Women with age less than 18 and more than 38 .
- Women with BMI less than 18.5 and more than 30 .
- Untreated tubal hydrosalpinges.
- Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.
- To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
- To establish a score for prediction of IVF/ICSI cycle success .
Read the detailed description
IVF is one of the most successful treatment of fertility, (1) however, several IVF cycles fail to achieve pregnancy (2).failure defined as three or more failed attempts of ICSI (3). Implantation failure is a complex in nature, may be due to structural or functional causes (3, 4).
that previously undiagnosed, misinterpreted initial diagnoses, or subtle newly added intrauterine abnormalities may be a significant cause of IVF failure (5, 6), studies say that intra-uterine pathologies represent 40-50 % of causes of ICSI failure (7, 8), hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum, or intrauterine adhesions could increase the pregnancy rate (9). so, Evaluation of the uterine cavity may become a routine investigation before assisted reproductive technology(ART) procedures (10).
In this study, we evaluate the relationship between the different uterine and cervical pathologies and decreased live birth rate.
- Conditions
- IVF
- Being tested
- IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVFProcedure or surgery
In vitro fertilization
| Study group | Role | What they receive |
|---|---|---|
| Group A | Women with hysteroscopically or ultrasonographic detected uterine anomalies(adenomyosis,fibroid) intracavitary lesions ( like polyp, adhesion or septum) and those with detected endometrial abnormalities (like hypervascularization,pale endometrium) ,cervical lesion and cervical canal lesion or pelvic lesion Receives: Procedure: IVF | |
| Group B | Matched women (eg. Age,parity, BMI, ovarian reserve….) with no uterine or ovarian abnormalities assessed by hysteroscopy or ultrasonography. Receives: Procedure: IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate with IVF/ICSI with uterine lesions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mostafa Ahmed, Assiut University
- Investigators
- Momen Kamel, Prof.dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939376
- Sponsor's protocol ID
- Uterine lesions and ICSI
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.
PubMed 16905025Dicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2.
PubMed 1426335Levi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021.
PubMed 15731311
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.
- ClinicalTrials.gov ID
- NCT04939376
- Acronym / sponsor ID
- Uterine lesions and ICSI
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 25 Jun 2021 (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.
- To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
- To establish a score for prediction of IVF/ICSI cycle success .
Detailed description
IVF is one of the most successful treatment of fertility, (1) however, several IVF cycles fail to achieve pregnancy (2).failure defined as three or more failed attempts of ICSI (3). Implantation failure is a complex in nature, may be due to structural or functional causes (3, 4).
that previously undiagnosed, misinterpreted initial diagnoses, or subtle newly added intrauterine abnormalities may be a significant cause of IVF failure (5, 6), studies say that intra-uterine pathologies represent 40-50 % of causes of ICSI failure (7, 8), hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum, or intrauterine adhesions could increase the pregnancy rate (9). so, Evaluation of the uterine cavity may become a routine investigation before assisted reproductive technology(ART) procedures (10).
In this study, we evaluate the relationship between the different uterine and cervical pathologies and decreased live birth rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: IVFWomen with hysteroscopically or ultrasonographic detected uterine anomalies(adenomyosis,fibroid) intracavitary lesions ( like polyp, adhesion or septum) and those with detected endometrial abnormalities (like hypervascularization,pale endometrium) ,cervical lesion and cervical canal lesion or pelvic lesion |
| Group B | – | Procedure: IVFMatched women (eg. Age,parity, BMI, ovarian reserve….) with no uterine or ovarian abnormalities assessed by hysteroscopy or ultrasonography. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between 18 and 38 years old. * An indication for IVF/ICSI.. * Women with BMI between 18.5 : 29.9 .
Key inclusion criteria (4 listed)
- Women between 18 and 38 years old.
Key exclusion criteria (5 listed)
- Refusal to join the study.
- Women with age less than 18 and more than 38 .
- Women with BMI less than 18.5 and more than 30 .
- Untreated tubal hydrosalpinges.
- Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
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 |
|---|---|---|
| IVFIn vitro fertilization | Procedure or surgery | Group A, Group B |
Primary outcome
Pregnancy rate
Time frame: Baseline
Pregnancy rate with IVF/ICSI with uterine lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 16905025Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.
- Background: PubMed 1426335Dicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2.
- Background: PubMed 15731311Levi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021.
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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.
Momen Kamel, Prof.dr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Assiut 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 4 inclusion and 5 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 30 Jun 2021. 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 Khaled Mostafa, Rsedent.dr (0201140465869, khaledmostafa849@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939376, which also lists 3 linked publications.
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 30 Jun 2021.