Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical PathologiesNCT04536389
Pregnancy Rates in Women With Normal Uterine Cavity With and Without Cervical Abnormalities
An observational study of Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to investigate the pregnancy rates in women with normal uterine cavity ,with and without cervical abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies
- What is being tested?
- Office Hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 30 Oct 2020
- 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
- Adult
Study population: All infertile women will be assessed in IVF\&ICSI unite of Women Health hospital,Assiut university and will be recruted according to the inclusion criteria.
Who may be able to join
- 1. Women between 18 and 38 years old. 2. An indication for IVF/ICSI. 3. Women with primary or secondary infertility. 4. Women with BMI between 20 \& 35.
Who cannot join
- 1. Refusal to join the study. 2. Untreated tubal hydrosalpinges. 3. Poor responders as assessed by AFC 4 or less, AMH O.8 ng/dl (nice 2013).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Women Health Hospital, Assiut University, Egypt
Asyut, 71111
Abdalla H Mohamed, +201002621430, abdalla82eg@gmail.com
Ashraf M Desouky, Eng, +201009342556, ashrafmdesouky@gmail.com
About this study
The aim of our study is to investigate the pregnancy rates in women with normal uterine cavity ,with and without cervical abnormalities.
Read the detailed description
The cervix is made up of the ectocervix and endocervix and is on average 3-4 cm long and 2.5 cm wide (Pardo et al., 2003; Mazouni et al., 2005; Robert et al., 2013). The ectocervix is the portion of the cervix projecting into the vagina. It is composed of non-keratinized stratified squamous epithelium and is divided into anterior and posterior lips. The squamocolumnar junction is the area where the epithelial cells of the endocervix and ectocervix meet (Herfs et al., 2013). In this area, the columnar cells of the endocervix undergo metaplasia to the squamous cells of the ectocervix. The opening of the ectocervix to the vagina is called the external os. Although studies of cervical length in non-pregnant women are few, it is acknowledged that the size and shape of both the cervix and the external os differ in women (Pardo et al., 2003; Mazouni et al., 2005) and vary with age, hormonal changes, parity and surgical treatments to the cervix.
Further evaluation of any cervical abnormalities by hysteroscopy eg. (choronic cervicitis , microcycstic epethelium ,micropolypi , cervical stenosis) before ICSI could address us to a hidden cause of infertility and may improve the pregnancy rates in ICSI cycles with prompt medical or surgical managment of such pathologies.
- Being tested
- Office Hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office HysteroscopyProcedure or surgery
The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity.
hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| group A | women with normal uterine cavity and normal cervix by office hysteroscopy. Receives: Procedure: Office Hysteroscopy | |
| group B | women with normal uterine cavity with hysteroscopically detected cervical abnormality. Receives: Procedure: Office Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
clinical pregnancy rate will be described
Measured: 7thweek of prgnancy for cardiac pulsations
Secondary outcomes (3)
chemical pregnancy rate
chemical pregnancy rate will be described
Measured: 4 weeks
Abortion rate
Abortion rate either first or second trimester abortion will be documented.
Measured: up to 28 weeks
preterm labour
preterm labour will be described
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical PathologiesStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Momen Ahmed Mohammed Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536389
- Sponsor's protocol ID
- pearlstudy
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pardo J, Yogev Y, Ben-Haroush A, Peled Y, Kaplan B, Hod M. Cervical length evaluation by transvaginal sonography in nongravid women with a history of preterm delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):464-6. doi: 10.1002/uog.116.
PubMed 12768558Mazouni C, Bretelle F, Blanc K, Heckenroth H, Haddad O, Agostini A, Cravello L, Blanc B, Gamerre M. Transvaginal sonographic evaluation of cervix length after cervical conization. J Ultrasound Med. 2005 Nov;24(11):1483-6. doi: 10.7863/jum.2005.24.11.1483.
PubMed 16239649Robert AL, Nicolas F, Lavoue V, Henno S, Mesbah H, Poree P, Leveque J. [Ultrasonographic evaluation of the uterine cervix length remaining after LOOP-excision]. J Gynecol Obstet Biol Reprod (Paris). 2014 Apr;43(4):288-93. doi: 10.1016/j.jgyn.2013.03.014. Epub 2013 Apr 25. French.
PubMed 23623518Herfs M, Vargas SO, Yamamoto Y, Howitt BE, Nucci MR, Hornick JL, McKeon FD, Xian W, Crum CP. A novel blueprint for 'top down' differentiation defines the cervical squamocolumnar junction during development, reproductive life, and neoplasia. J Pathol. 2013 Feb;229(3):460-8. doi: 10.1002/path.4110.
PubMed 23007879
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Rates in Women With Normal Uterine Cavity With and Without Cervical Abnormalities
- ClinicalTrials.gov ID
- NCT04536389
- Acronym / sponsor ID
- pearlstudy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 2 Sep 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.
The aim of our study is to investigate the pregnancy rates in women with normal uterine cavity ,with and without cervical abnormalities.
Detailed description
The cervix is made up of the ectocervix and endocervix and is on average 3-4 cm long and 2.5 cm wide (Pardo et al., 2003; Mazouni et al., 2005; Robert et al., 2013). The ectocervix is the portion of the cervix projecting into the vagina. It is composed of non-keratinized stratified squamous epithelium and is divided into anterior and posterior lips. The squamocolumnar junction is the area where the epithelial cells of the endocervix and ectocervix meet (Herfs et al., 2013). In this area, the columnar cells of the endocervix undergo metaplasia to the squamous cells of the ectocervix. The opening of the ectocervix to the vagina is called the external os. Although studies of cervical length in non-pregnant women are few, it is acknowledged that the size and shape of both the cervix and the external os differ in women (Pardo et al., 2003; Mazouni et al., 2005) and vary with age, hormonal changes, parity and surgical treatments to the cervix.
Further evaluation of any cervical abnormalities by hysteroscopy eg. (choronic cervicitis , microcycstic epethelium ,micropolypi , cervical stenosis) before ICSI could address us to a hidden cause of infertility and may improve the pregnancy rates in ICSI cycles with prompt medical or surgical managment of such pathologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: Office Hysteroscopywomen with normal uterine cavity and normal cervix by office hysteroscopy. |
| group B | – | Procedure: Office Hysteroscopywomen with normal uterine cavity with hysteroscopically detected cervical abnormality. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All infertile women will be assessed in IVF\&ICSI unite of Women Health hospital,Assiut university and will be recruted according to the inclusion criteria.
Key inclusion criteria (1 listed)
- 1. Women between 18 and 38 years old. 2. An indication for IVF/ICSI. 3. Women with primary or secondary infertility. 4. Women with BMI between 20 \& 35.
Key exclusion criteria (1 listed)
- 1. Refusal to join the study. 2. Untreated tubal hydrosalpinges. 3. 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 |
|---|---|---|
| Office HysteroscopyThe hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity. hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment. | Procedure or surgery | group A, group B |
Primary outcome
clinical pregnancy rate
Time frame: 7thweek of prgnancy for cardiac pulsations
clinical pregnancy rate will be described
3 secondary outcomes
chemical pregnancy rate
Time frame: 4 weeks
Abortion rate
Time frame: up to 28 weeks
preterm labour
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Results publication: PubMed 12768558Pardo J, Yogev Y, Ben-Haroush A, Peled Y, Kaplan B, Hod M. Cervical length evaluation by transvaginal sonography in nongravid women with a history of preterm delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):464-6. doi: 10.1002/uog.116.
- Results publication: PubMed 16239649Mazouni C, Bretelle F, Blanc K, Heckenroth H, Haddad O, Agostini A, Cravello L, Blanc B, Gamerre M. Transvaginal sonographic evaluation of cervix length after cervical conization. J Ultrasound Med. 2005 Nov;24(11):1483-6. doi: 10.7863/jum.2005.24.11.1483.
- Results publication: PubMed 23623518Robert AL, Nicolas F, Lavoue V, Henno S, Mesbah H, Poree P, Leveque J. [Ultrasonographic evaluation of the uterine cervix length remaining after LOOP-excision]. J Gynecol Obstet Biol Reprod (Paris). 2014 Apr;43(4):288-93. doi: 10.1016/j.jgyn.2013.03.014. Epub 2013 Apr 25. French.
- Results publication: PubMed 23007879Herfs M, Vargas SO, Yamamoto Y, Howitt BE, Nucci MR, Hornick JL, McKeon FD, Xian W, Crum CP. A novel blueprint for 'top down' differentiation defines the cervical squamocolumnar junction during development, reproductive life, and neoplasia. J Pathol. 2013 Feb;229(3):460-8. doi: 10.1002/path.4110.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracytoplasmic Sperm Injection ,Hysteroscopicaly Detected Cervical Pathologies, run by Assiut University 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 2 Sep 2020. 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 Ahmed M. Kamel, MSc&MBBH (01003627020 ext. 002, ahmedmomen414@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: 7thweek of prgnancy for cardiac pulsations). 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 NCT04536389, which also lists 4 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 2 Sep 2020.