Intracytoplasmic Sperm InjectionNCT03680690
Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
An observational study of Intracytoplasmic Sperm Injection, run by Assiut University.
Trial summary
The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles. 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
- Intracytoplasmic Sperm Injection
- What is being tested?
- hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 28 Feb 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
- Healthy volunteers accepted
- Adult
Study population: all infertile females will be assesed in IVF unite of women's health Hospital and will be recruted according to the inclusion criteria
Who may be able to join
- Women between 18 and 38 years old.
- An indication for IVF/ICSI.
- Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
- Women with primary or secondary infertility.
- Women with BMI between 20 \& 35.
Who cannot join
- Refusal to join the study.
- 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
The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.
Read the detailed description
Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome.
A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected.
However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted.
An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.
- Conditions
- Intracytoplasmic Sperm Injection
- Being tested
- hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopyProcedure or surgery
Also called hysteroscopic uterine lesion detection or correction
office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
| Study group | Role | What they receive |
|---|---|---|
| Group A | women with normal uterus,detected by hysteroscopy. Receives: Procedure: hysteroscopy | |
| Group B | Women with detected or corrected uterine cavitary lesions by hysteroscopy. Receives: Procedure: 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 evaluated
Measured: 7th week of pregnancy for cardiac pulsations.
Secondary outcomes (4)
Chemical pregnancy rate Chemical pregnancy rate
Chemical pregnancy rate
Chemical pregnancy rate
Measured: 4 weeks
Implantation rate
Implantation rate for assessment of implanted embryos
Measured: 6 weeks
Abortion rate
Abortion rate will be observed
Measured: up to 28 week
Preterm labour rate
Delivary before term 37 weeks of pregnancy
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 posted21 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intracytoplasmic Sperm InjectionStudies 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
- 244 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
- Investigators
- Ahmed Youssef, MD/MSC, Study chair, women's health hospital,Assiut universityIbrahim Mohammed, MD/MSc, Study director, women's health hospital,Assiut universitySayed Moustafa, MD/MSC, Principal investigator, women's health hospital,Assiut universityAhmed Kamel, MSC/MBBh, Principal investigator, women's health hospital,Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680690
- Sponsor's protocol ID
- pregnancy rate in ICSI cycles
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Polanski LT, Baumgarten MN, Quenby S, Brosens J, Campbell BK, Raine-Fenning NJ. What exactly do we mean by 'recurrent implantation failure'? A systematic review and opinion. Reprod Biomed Online. 2014 Apr;28(4):409-23. doi: 10.1016/j.rbmo.2013.12.006. Epub 2014 Jan 17.
PubMed 24581986Coughlan C, Walters S, Ledger W, Li TC. A comparison of psychological stress among women with and without reproductive failure. Int J Gynaecol Obstet. 2014 Feb;124(2):143-7. doi: 10.1016/j.ijgo.2013.08.006. Epub 2013 Oct 31.
PubMed 24290538Zeyneloglu HB, Onalan G. Remedies for recurrent implantation failure. Semin Reprod Med. 2014 Jul;32(4):297-305. doi: 10.1055/s-0034-1375182. Epub 2014 Jun 11.
PubMed 24919029Papathanasiou A, Bhattacharya S. Prognostic factors for IVF success: diagnostic testing and evidence-based interventions. Semin Reprod Med. 2015 Mar;33(2):65-76. doi: 10.1055/s-0035-1545364. Epub 2015 Mar 3.
PubMed 25734344Moini A, Kiani K, Ghaffari F, Hosseini F. Hysteroscopic findings in patients with a history of two implantation failures following in vitro fertilization. Int J Fertil Steril. 2012 Apr;6(1):27-30. Epub 2012 Jun 19.
PubMed 25505508Cenksoy P, Ficicioglu C, Yildirim G, Yesiladali M. Hysteroscopic findings in women with recurrent IVF failures and the effect of correction of hysteroscopic findings on subsequent pregnancy rates. Arch Gynecol Obstet. 2013 Feb;287(2):357-60. doi: 10.1007/s00404-012-2627-5. Epub 2012 Nov 27.
PubMed 23183783Dicker 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 1426335La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998 Aug;70(2):378-80. doi: 10.1016/s0015-0282(98)00147-2.
PubMed 9696242Levi 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 15731311El-Toukhy T, Campo R, Khalaf Y, Tabanelli C, Gianaroli L, Gordts SS, Gordts S, Mestdagh G, Mardesic T, Voboril J, Marchino GL, Benedetto C, Al-Shawaf T, Sabatini L, Seed PT, Gergolet M, Grimbizis G, Harb H, Coomarasamy A. Hysteroscopy in recurrent in-vitro fertilisation failure (TROPHY): a multicentre, randomised controlled trial. Lancet. 2016 Jun 25;387(10038):2614-2621. doi: 10.1016/S0140-6736(16)00258-0. Epub 2016 Apr 27.
PubMed 27132053
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles
- ClinicalTrials.gov ID
- NCT03680690
- Acronym / sponsor ID
- pregnancy rate in ICSI cycles
- Conditions
- Intracytoplasmic Sperm Injection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 21 Sep 2018 (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 the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.
Detailed description
Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome.
A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected.
However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted.
An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: hysteroscopywomen with normal uterus,detected by hysteroscopy. |
| Group B | – | Procedure: hysteroscopyWomen with detected or corrected uterine cavitary lesions by hysteroscopy. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all infertile females will be assesed in IVF unite of women's health Hospital and will be recruted according to the inclusion criteria
Key inclusion criteria (5 listed)
- Women between 18 and 38 years old.
- An indication for IVF/ICSI.
- Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
- Women with primary or secondary infertility.
- Women with BMI between 20 \& 35.
Key exclusion criteria (3 listed)
- Refusal to join the study.
- 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 |
|---|---|---|
| hysteroscopyAlso: hysteroscopic uterine lesion detection or correctionoffice hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on. | Procedure or surgery | Group A, Group B |
Primary outcome
Clinical pregnancy rate
Time frame: 7th week of pregnancy for cardiac pulsations.
Clinical pregnancy rate Will be evaluated
4 secondary outcomes
Chemical pregnancy rate Chemical pregnancy rate
Time frame: 4 weeks
Implantation rate
Time frame: 6 weeks
Abortion rate
Time frame: up to 28 week
Preterm labour rate
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 24 Sep 2018.
- Results publication: PubMed 24581986Polanski LT, Baumgarten MN, Quenby S, Brosens J, Campbell BK, Raine-Fenning NJ. What exactly do we mean by 'recurrent implantation failure'? A systematic review and opinion. Reprod Biomed Online. 2014 Apr;28(4):409-23. doi: 10.1016/j.rbmo.2013.12.006. Epub 2014 Jan 17.
- Results publication: PubMed 24290538Coughlan C, Walters S, Ledger W, Li TC. A comparison of psychological stress among women with and without reproductive failure. Int J Gynaecol Obstet. 2014 Feb;124(2):143-7. doi: 10.1016/j.ijgo.2013.08.006. Epub 2013 Oct 31.
- Results publication: PubMed 24919029Zeyneloglu HB, Onalan G. Remedies for recurrent implantation failure. Semin Reprod Med. 2014 Jul;32(4):297-305. doi: 10.1055/s-0034-1375182. Epub 2014 Jun 11.
- Results publication: PubMed 25734344Papathanasiou A, Bhattacharya S. Prognostic factors for IVF success: diagnostic testing and evidence-based interventions. Semin Reprod Med. 2015 Mar;33(2):65-76. doi: 10.1055/s-0035-1545364. Epub 2015 Mar 3.
- Results publication: PubMed 25505508Moini A, Kiani K, Ghaffari F, Hosseini F. Hysteroscopic findings in patients with a history of two implantation failures following in vitro fertilization. Int J Fertil Steril. 2012 Apr;6(1):27-30. Epub 2012 Jun 19.
- Results publication: PubMed 23183783Cenksoy P, Ficicioglu C, Yildirim G, Yesiladali M. Hysteroscopic findings in women with recurrent IVF failures and the effect of correction of hysteroscopic findings on subsequent pregnancy rates. Arch Gynecol Obstet. 2013 Feb;287(2):357-60. doi: 10.1007/s00404-012-2627-5. Epub 2012 Nov 27.
- Results publication: 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.
- Results publication: PubMed 9696242La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998 Aug;70(2):378-80. doi: 10.1016/s0015-0282(98)00147-2.
- Results publication: 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.
- Results publication: PubMed 27132053El-Toukhy T, Campo R, Khalaf Y, Tabanelli C, Gianaroli L, Gordts SS, Gordts S, Mestdagh G, Mardesic T, Voboril J, Marchino GL, Benedetto C, Al-Shawaf T, Sabatini L, Seed PT, Gergolet M, Grimbizis G, Harb H, Coomarasamy A. Hysteroscopy in recurrent in-vitro fertilisation failure (TROPHY): a multicentre, randomised controlled trial. Lancet. 2016 Jun 25;387(10038):2614-2621. doi: 10.1016/S0140-6736(16)00258-0. Epub 2016 Apr 27.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Youssef, MD/MSC study chair
women's health hospital,Assiut university
Ibrahim Mohammed, MD/MSc study director
women's health hospital,Assiut university
Sayed Moustafa, MD/MSC principal investigator
women's health hospital,Assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of Intracytoplasmic Sperm Injection, 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 5 inclusion and 3 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 24 Sep 2018. 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 Ahmed Kamel, MSc/Mbbh (00201003627020, 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: 7th week of pregnancy 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 NCT03680690, which also lists 10 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 24 Sep 2018.