Primary Infertility UnspecifiedNCT02416596
Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility
A study testing Hysteroscopy and Hysteroscope in people with Primary Infertility Unspecified and Infertility, run by Ain Shams Maternity Hospital.
Trial summary
The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Infertility Unspecified, Infertility, Ovarian Hyperstimulation
- What is being tested?
- Hysteroscopy and Hysteroscope
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
- No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
- Patients with unexplained primary infertility.
Who cannot join
- Patients undergoing IVF using other protocols of induction.
- Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
- Other causes of infertility rather than unexplained factor.
- Unexplained poor responders during the pending ICSI cycle.
- Patients with abnormal findings at hysteroscopy.
Trial locations and contacts
No sites are listed yet.
Moustafa F Gomaa, PhD contact
About this study
Official title: Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial
The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.
Read the detailed description
Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.
Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.
- Being tested
- Hysteroscopy, Hysteroscope
- Keywords
- ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Also called ROH: Routine Office Hysteroscopy
Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle.
All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum.
Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection.
HysteroscopeDevice
The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy).
Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Group Undergoing Hysterosopy | Experimental | This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle. Receives: Procedure: Hysteroscopy; Device: Hysteroscope |
| Group With No intervention | No intervention | This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Pregnancy
Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)
Measured: 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Primary Infertility UnspecifiedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdulreheem, Ain Shams Maternity Hospital
- Investigators
- Khaled H Swaydan, PhD, Study director, Ain Shams University (Obs&Gyn)Ahmed K Mekled, PhD, Study chair, Ain Shams University (Obs&Gyn)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416596
- Sponsor's protocol ID
- ASMH-RH1
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El-Toukhy T, Sunkara SK, Coomarasamy A, Grace J, Khalaf Y. Outpatient hysteroscopy and subsequent IVF cycle outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2008 May;16(5):712-9. doi: 10.1016/s1472-6483(10)60486-5.
PubMed 18492377Pundir J, Pundir V, Omanwa K, Khalaf Y, El-Toukhy T. Hysteroscopy prior to the first IVF cycle: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Feb;28(2):151-61. doi: 10.1016/j.rbmo.2013.09.025. Epub 2013 Oct 5.
PubMed 24365027Loverro G, Nappi L, Vicino M, Carriero C, Vimercati A, Selvaggi L. Uterine cavity assessment in infertile women: comparison of transvaginal sonography and hysteroscopy. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):67-71. doi: 10.1016/s0301-2115(01)00434-1.
PubMed 11728660Karayalcin R, Ozyer S, Ozcan S, Uzunlar O, Gurlek B, Moraloglu O, Batioglu S. Office hysteroscopy improves pregnancy rates following IVF. Reprod Biomed Online. 2012 Sep;25(3):261-6. doi: 10.1016/j.rbmo.2012.05.013. Epub 2012 Jun 16.
PubMed 22818094De Placido G, Clarizia R, Cadente C, Castaldo G, Romano C, Mollo A, Alviggi C, Conforti S. Compliance and diagnostic efficacy of mini-hysteroscopy versus traditional hysteroscopy in infertility investigation. Eur J Obstet Gynecol Reprod Biol. 2007 Nov;135(1):83-7. doi: 10.1016/j.ejogrb.2007.02.028. Epub 2007 May 3.
PubMed 17481803Almog B, Shalom-Paz E, Dufort D, Tulandi T. Promoting implantation by local injury to the endometrium. Fertil Steril. 2010 Nov;94(6):2026-9. doi: 10.1016/j.fertnstert.2009.12.075. Epub 2010 Feb 19.
PubMed 20171615Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PubMed 12798877Bosteels J, Weyers S, Puttemans P, Panayotidis C, Van Herendael B, Gomel V, Mol BW, Mathieu C, D'Hooghe T. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Hum Reprod Update. 2010 Jan-Feb;16(1):1-11. doi: 10.1093/humupd/dmp033.
PubMed 19744944Huang LN, Tan J, Hitkari J, Dahan MH. Should IVF be used as first-line treatment or as a last resort? A debate presented at the 2013 Canadian Fertility and Andrology Society meeting. Reprod Biomed Online. 2015 Feb;30(2):128-36. doi: 10.1016/j.rbmo.2014.10.004. Epub 2014 Oct 14.
PubMed 25498596Hughes E, Brown J, Collins JJ, Vanderkerchove P. Clomiphene citrate for unexplained subfertility in women. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000057. doi: 10.1002/14651858.CD000057.pub2.
PubMed 20091498Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167.
PubMed 17709558
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02416596
- Acronym / sponsor ID
- ASMH-RH1
- Keywords
- ICSI, IVF, hysteroscopy, Supervision, In-vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- 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 present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.
Detailed description
Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.
Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Undergoing Hysterosopy | Experimental | Procedure: Hysteroscopy, Device: HysteroscopeThis group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle. |
| Group With No intervention | No intervention | –This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
- No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
- Patients with unexplained primary infertility.
Key exclusion criteria (5 listed)
- Patients undergoing IVF using other protocols of induction.
- Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
- Other causes of infertility rather than unexplained factor.
- Unexplained poor responders during the pending ICSI cycle.
- Patients with abnormal findings at hysteroscopy.
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: ROH: Routine Office HysteroscopyOffice hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle. All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum. Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection. | Procedure or surgery | Group Undergoing Hysterosopy |
| HysteroscopeThe device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy). Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg | Device | Group Undergoing Hysterosopy |
Primary outcome
Biochemical Pregnancy
Time frame: 2-6 weeks
Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Background: PubMed 18492377El-Toukhy T, Sunkara SK, Coomarasamy A, Grace J, Khalaf Y. Outpatient hysteroscopy and subsequent IVF cycle outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2008 May;16(5):712-9. doi: 10.1016/s1472-6483(10)60486-5.
- Background: PubMed 24365027Pundir J, Pundir V, Omanwa K, Khalaf Y, El-Toukhy T. Hysteroscopy prior to the first IVF cycle: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Feb;28(2):151-61. doi: 10.1016/j.rbmo.2013.09.025. Epub 2013 Oct 5.
- Background: PubMed 11728660Loverro G, Nappi L, Vicino M, Carriero C, Vimercati A, Selvaggi L. Uterine cavity assessment in infertile women: comparison of transvaginal sonography and hysteroscopy. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):67-71. doi: 10.1016/s0301-2115(01)00434-1.
- Background: PubMed 22818094Karayalcin R, Ozyer S, Ozcan S, Uzunlar O, Gurlek B, Moraloglu O, Batioglu S. Office hysteroscopy improves pregnancy rates following IVF. Reprod Biomed Online. 2012 Sep;25(3):261-6. doi: 10.1016/j.rbmo.2012.05.013. Epub 2012 Jun 16.
- Background: PubMed 17481803De Placido G, Clarizia R, Cadente C, Castaldo G, Romano C, Mollo A, Alviggi C, Conforti S. Compliance and diagnostic efficacy of mini-hysteroscopy versus traditional hysteroscopy in infertility investigation. Eur J Obstet Gynecol Reprod Biol. 2007 Nov;135(1):83-7. doi: 10.1016/j.ejogrb.2007.02.028. Epub 2007 May 3.
- Background: PubMed 20171615Almog B, Shalom-Paz E, Dufort D, Tulandi T. Promoting implantation by local injury to the endometrium. Fertil Steril. 2010 Nov;94(6):2026-9. doi: 10.1016/j.fertnstert.2009.12.075. Epub 2010 Feb 19.
- Background: PubMed 12798877Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
- Background: PubMed 19744944Bosteels J, Weyers S, Puttemans P, Panayotidis C, Van Herendael B, Gomel V, Mol BW, Mathieu C, D'Hooghe T. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Hum Reprod Update. 2010 Jan-Feb;16(1):1-11. doi: 10.1093/humupd/dmp033.
- Background: PubMed 25498596Huang LN, Tan J, Hitkari J, Dahan MH. Should IVF be used as first-line treatment or as a last resort? A debate presented at the 2013 Canadian Fertility and Andrology Society meeting. Reprod Biomed Online. 2015 Feb;30(2):128-36. doi: 10.1016/j.rbmo.2014.10.004. Epub 2014 Oct 14.
- Background: PubMed 20091498Hughes E, Brown J, Collins JJ, Vanderkerchove P. Clomiphene citrate for unexplained subfertility in women. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000057. doi: 10.1002/14651858.CD000057.pub2.
- Background: PubMed 17709558Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167.
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.
Moustafa F Gomaa, PhD contact
Khaled H Swaydan, PhD study director
Ain Shams University (Obs&Gyn)
Ahmed K Mekled, PhD study chair
Ain Shams University (Obs&Gyn)
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy and Hysteroscope in people with Primary Infertility Unspecified and Infertility, run by Ain Shams Maternity Hospital.
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 3 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 15 Apr 2015. 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 Amr A. Abdulreheem, MBBCh (+201006774459, amro984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Pregnancy (time frame: 2-6 weeks). 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 NCT02416596, which also lists 11 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 15 Apr 2015.