Unexplained InfertilityNCT03380364
Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility
A study testing hystroscope in people with Unexplained Infertility, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the value of hysteroscopy in unexplained infertility. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- hystroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to Feb 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. All women aged (20-35) years old. 2. Unexplained infertility
Who cannot join
- 1. Female genital tract cancer, including cervical or uterine cancer 2. Active pelvic infection 3. Known uterine factor for infertility.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of obstetrics and gynaecology, faculty of medicine, Ain shams university
Cairo, 11591
HANAN H EL KHATEEB, MS, 201008834646, drsamehhabib@yahoo.com
About this study
The aim of this work is to assess the value of hysteroscopy in unexplained infertility.
Read the detailed description
The diagnosis of unexplained infertility is one of exclusion and is made only after an infertility evaluation has failed to reveal abnormalities. There is no consensus on which tests should be performed before making this diagnosis (Salim et al., 2011).
The Europe society for human and embryology (ESHRE) suggested standard diagnostic tests for infertility evaluation. These tests include semen analysis, demonstration of tubal patency by hystosalpingography (HSG) or laparascopy and laboratory assessment of ovulation (Polisseni et al., 2003). Moreover post coital test has been included by some authors as a fundamental requirement before the diagnosis of unexplained infertility while other authors found that it is unnecessary however conducting additional investigation and treating any abnormalities detected may be effective in management of women with unexplained infertility especially in older couples (Wortman et al., 2013).
For evaluation of the uterine cavity, the basic work-up consists of transvaginal sonography (TVS) with or without the use of saline or gel as a contrast medium, possibly followed by either HSG or hysteroscopy to directly assess the uterine cavity.
Both TVS, as well as saline infusion sonography (SIS) and gel instillation sonography (GIS) are inexpensive, non-invasive and have been shown to be excellent diagnostic tool to detect subtle intrauterine abnormalities (Rodrigues et al., 2014).
However, hysteroscopy allows direct visualization of the endometrial lining and detects multiple lesions and subtle uterine abnormalities that cannot be identified by the previous techniques. Moreover, hysteroscopy enables treatment of small uterine pathology in the same setting. Therefore, it is frequently referred to as the golden standard. Many studies have concluded that whenever laparoscopy is performed, it should be combined with hysteroscopy in order to complete the assessment before starting the infertility treatment (Chan et al., 2011).
In the assisted reproductive technique, a number of studies was conducted on women before in vitro fertilization (IVF) cycle revealed that the prevalence of un suspected intra uterine abnormalities, diagnosed by hysteroscopy prior to IVF cycles was 11% - 45% (Shokeir et al., 2011).
Although the role of these subtle lesions as a cause of infertility is debatable,( Kilic et al., 2013) hysteroscopic assessment and treatment of any abnormalities detected has improved the clinical pregnancy rate , live birth, and considered cost effective before IVF cycles (Grimbizis et al., 2003) .
It is widely accepted that a complete infertility workup includes an evaluation of the uterine cavity (Chan et al., 2011). Uterine abnormalities, congenital or acquired, are implicated as one of the causes of infertility. In fact, infertility related to uterine cavity abnormalities has been estimated to be the causal factor in as many as 10% to 15% of couples seeking treatment (Romani et al. 2013).
Hysteroscopy enables visualisation of the uterine cavity and allows the diagnosis and surgical treatment of intrauterine pathology. (Umranikar et al., 2016). Direct view of uterine cavity offers a significant advantage over other blind or indirect diagnostic methods. Although , hystrosalpingography (HSG) is reported to be as accurate as hysteroscopy in the diagnosis of normal and abnormal cavities, the nature of intrauterine filling defects is more accurately revealed by hysteroscopy (Jenneke et al.,2013).
The role of hysteroscopy in infertility investigation is to detect possible intrauterine change that could interfere with implantation or growth, or both, of the conceptus (Scholten et al., 2013) and to evaluate the benefit of direct treatment modalities in restoring a normal endometrial environment (Prasanta et al., 2013).
Several studies have been also performed to find out that if hystroscopic treatment of intrauterine pathologies increases the cause of failure of IVF-ET (Fatemi et al., 2010) and therefore hysteroscopy should be a part of infertility workup for all patients prior to undergoing IVF treatment and have also recommended screening of the uterus by hysteroscopy before proceeding with IVF/ICSI, to minimize implantation failure (Ryan et al. 2005).
The potential risk of diagnostic hysteroscopy are rare in most series (0-1%) especially in office procedure (John et al., 2013), while (5-24%) of operative cessions may result in intraoperative or early postoperative complications which include infection, bleeding, and even perforation of the uterus. Certain factors are considered contraindication to hystroscope like PID (Aydeniz et al., 2004).
- Conditions
- Unexplained Infertility
- Being tested
- hystroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hystroscopeDevice
Procedure: Hysteroscopy Office hysteroscopy will be performed during the proliferative phaseof the 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.
Other Name: ROH: Routine Office Hysteroscopy Device: Hysteroscope The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 5-mm diameter diagnostic rigid 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 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle. Receives: Device: hystroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Apr 2018
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Habib, Ain Shams University
- Investigators
- Amr M Al helaly, PhD, Study director, Ain Shams University (Obs&Gyn)Kaled S Mohamed, PhD, Study chair, Ain Shams University (Obs&Gyn)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380364
- Sponsor's protocol ID
- routine hysteroscopy
- Status last verified
- Apr 2018
- First submitted
- 17 Dec 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aydeniz B, Gruber IV, Schauf B, Kurek R, Meyer A, Wallwiener D. A multicenter survey of complications associated with 21,676 operative hysteroscopies. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):160-4. doi: 10.1016/s0301-2115(02)00106-9.
PubMed 12206931Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.
PubMed 21705770Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
PubMed 21830244Fatemi HM, Kasius JC, Timmermans A, van Disseldorp J, Fauser BC, Devroey P, Broekmans FJ. Prevalence of unsuspected uterine cavity abnormalities diagnosed by office hysteroscopy prior to in vitro fertilization. Hum Reprod. 2010 Aug;25(8):1959-65. doi: 10.1093/humrep/deq150. Epub 2010 Jun 22.
PubMed 20570971Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update. 2001 Mar-Apr;7(2):161-74. doi: 10.1093/humupd/7.2.161.
PubMed 11284660Kasius JC, Eijkemans RJ, Mol BW, Fauser BC, Fatemi HM, Broekmans FJ. Cost-effectiveness of hysteroscopy screening for infertile women. Reprod Biomed Online. 2013 Jun;26(6):619-26. doi: 10.1016/j.rbmo.2013.02.015. Epub 2013 Mar 14.
PubMed 23602685Keats JP. Patient safety in the obstetric and gynecologic office setting. Obstet Gynecol Clin North Am. 2013 Dec;40(4):611-23. doi: 10.1016/j.ogc.2013.08.004.
PubMed 24286992Kilic Y, Bastu E, Ergun B. Validity and efficacy of office hysteroscopy before in vitro fertilization treatment. Arch Gynecol Obstet. 2013 Mar;287(3):577-81. doi: 10.1007/s00404-012-2584-z. Epub 2012 Oct 6.
PubMed 23053317Polisseni F, Bambirra EA, Camargos AF. Detection of chronic endometritis by diagnostic hysteroscopy in asymptomatic infertile patients. Gynecol Obstet Invest. 2003;55(4):205-10. doi: 10.1159/000072075.
PubMed 12904693Nayak PK, Mahapatra PC, Mallick J, Swain S, Mitra S, Sahoo J. Role of diagnostic hystero-laparoscopy in the evaluation of infertility: A retrospective study of 300 patients. J Hum Reprod Sci. 2013 Jan;6(1):32-4. doi: 10.4103/0974-1208.112378.
PubMed 23869148Ray A, Shah A, Gudi A, Homburg R. Unexplained infertility: an update and review of practice. Reprod Biomed Online. 2012 Jun;24(6):591-602. doi: 10.1016/j.rbmo.2012.02.021. Epub 2012 Mar 7.
PubMed 22503948Romani F, Guido M, Morciano A, Martinez D, Gaglione R, Lanzone A, Selvaggi L. The use of different size-hysteroscope in office hysteroscopy: our experience. Arch Gynecol Obstet. 2013 Dec;288(6):1355-9. doi: 10.1007/s00404-013-2932-7. Epub 2013 Jun 25.
PubMed 23797933Ryan GL, Syrop CH, Van Voorhis BJ. Role, epidemiology, and natural history of benign uterine mass lesions. Clin Obstet Gynecol. 2005 Jun;48(2):312-24. doi: 10.1097/01.grf.0000159538.27221.8c. No abstract available.
PubMed 15805789Salim S, Won H, Nesbitt-Hawes E, Campbell N, Abbott J. Diagnosis and management of endometrial polyps: a critical review of the literature. J Minim Invasive Gynecol. 2011 Sep-Oct;18(5):569-81. doi: 10.1016/j.jmig.2011.05.018. Epub 2011 Jul 23.
PubMed 21783430Scholten I, Moolenaar LM, Gianotten J, van der Veen F, Hompes PG, Mol BW, Steures P. Long term outcome in subfertile couples with isolated cervical factor. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):429-33. doi: 10.1016/j.ejogrb.2013.06.042. Epub 2013 Aug 3.
PubMed 23921361
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Routine Hysteroscopy in Management of Cases of Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03380364
- Acronym / sponsor ID
- routine hysteroscopy
- Conditions
- Unexplained Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 21 Dec 2017 (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 this work is to assess the value of hysteroscopy in unexplained infertility.
Detailed description
The diagnosis of unexplained infertility is one of exclusion and is made only after an infertility evaluation has failed to reveal abnormalities. There is no consensus on which tests should be performed before making this diagnosis (Salim et al., 2011).
The Europe society for human and embryology (ESHRE) suggested standard diagnostic tests for infertility evaluation. These tests include semen analysis, demonstration of tubal patency by hystosalpingography (HSG) or laparascopy and laboratory assessment of ovulation (Polisseni et al., 2003). Moreover post coital test has been included by some authors as a fundamental requirement before the diagnosis of unexplained infertility while other authors found that it is unnecessary however conducting additional investigation and treating any abnormalities detected may be effective in management of women with unexplained infertility especially in older couples (Wortman et al., 2013).
For evaluation of the uterine cavity, the basic work-up consists of transvaginal sonography (TVS) with or without the use of saline or gel as a contrast medium, possibly followed by either HSG or hysteroscopy to directly assess the uterine cavity.
Both TVS, as well as saline infusion sonography (SIS) and gel instillation sonography (GIS) are inexpensive, non-invasive and have been shown to be excellent diagnostic tool to detect subtle intrauterine abnormalities (Rodrigues et al., 2014).
However, hysteroscopy allows direct visualization of the endometrial lining and detects multiple lesions and subtle uterine abnormalities that cannot be identified by the previous techniques. Moreover, hysteroscopy enables treatment of small uterine pathology in the same setting. Therefore, it is frequently referred to as the golden standard. Many studies have concluded that whenever laparoscopy is performed, it should be combined with hysteroscopy in order to complete the assessment before starting the infertility treatment (Chan et al., 2011).
In the assisted reproductive technique, a number of studies was conducted on women before in vitro fertilization (IVF) cycle revealed that the prevalence of un suspected intra uterine abnormalities, diagnosed by hysteroscopy prior to IVF cycles was 11% - 45% (Shokeir et al., 2011).
Although the role of these subtle lesions as a cause of infertility is debatable,( Kilic et al., 2013) hysteroscopic assessment and treatment of any abnormalities detected has improved the clinical pregnancy rate , live birth, and considered cost effective before IVF cycles (Grimbizis et al., 2003) .
It is widely accepted that a complete infertility workup includes an evaluation of the uterine cavity (Chan et al., 2011). Uterine abnormalities, congenital or acquired, are implicated as one of the causes of infertility. In fact, infertility related to uterine cavity abnormalities has been estimated to be the causal factor in as many as 10% to 15% of couples seeking treatment (Romani et al. 2013).
Hysteroscopy enables visualisation of the uterine cavity and allows the diagnosis and surgical treatment of intrauterine pathology. (Umranikar et al., 2016). Direct view of uterine cavity offers a significant advantage over other blind or indirect diagnostic methods. Although , hystrosalpingography (HSG) is reported to be as accurate as hysteroscopy in the diagnosis of normal and abnormal cavities, the nature of intrauterine filling defects is more accurately revealed by hysteroscopy (Jenneke et al.,2013).
The role of hysteroscopy in infertility investigation is to detect possible intrauterine change that could interfere with implantation or growth, or both, of the conceptus (Scholten et al., 2013) and to evaluate the benefit of direct treatment modalities in restoring a normal endometrial environment (Prasanta et al., 2013).
Several studies have been also performed to find out that if hystroscopic treatment of intrauterine pathologies increases the cause of failure of IVF-ET (Fatemi et al., 2010) and therefore hysteroscopy should be a part of infertility workup for all patients prior to undergoing IVF treatment and have also recommended screening of the uterus by hysteroscopy before proceeding with IVF/ICSI, to minimize implantation failure (Ryan et al. 2005).
The potential risk of diagnostic hysteroscopy are rare in most series (0-1%) especially in office procedure (John et al., 2013), while (5-24%) of operative cessions may result in intraoperative or early postoperative complications which include infection, bleeding, and even perforation of the uterus. Certain factors are considered contraindication to hystroscope like PID (Aydeniz et al., 2004).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Undergoing Hysterosopy | Experimental | Device: hystroscopeThis group will include 75 women with unexplained infertility. 5 mm rigid sheath Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. All women aged (20-35) years old. 2. Unexplained infertility
Key exclusion criteria (1 listed)
- 1. Female genital tract cancer, including cervical or uterine cancer 2. Active pelvic infection 3. Known uterine factor for 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 |
|---|---|---|
| hystroscopeProcedure: Hysteroscopy Office hysteroscopy will be performed during the proliferative phaseof the 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. Other Name: ROH: Routine Office Hysteroscopy Device: Hysteroscope The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 5-mm diameter diagnostic rigid 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
Pregnancy
Time frame: 6 months
Biochemical and clinical Pregnancy Biochemical pregnancy will be determined by a positive pregnancy test performed 1week after a missed period and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after a missed period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Results publication: PubMed 12206931Aydeniz B, Gruber IV, Schauf B, Kurek R, Meyer A, Wallwiener D. A multicenter survey of complications associated with 21,676 operative hysteroscopies. Eur J Obstet Gynecol Reprod Biol. 2002 Sep 10;104(2):160-4. doi: 10.1016/s0301-2115(02)00106-9.
- Results publication: PubMed 21705770Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.
- Results publication: PubMed 21830244Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.
- Results publication: PubMed 20570971Fatemi HM, Kasius JC, Timmermans A, van Disseldorp J, Fauser BC, Devroey P, Broekmans FJ. Prevalence of unsuspected uterine cavity abnormalities diagnosed by office hysteroscopy prior to in vitro fertilization. Hum Reprod. 2010 Aug;25(8):1959-65. doi: 10.1093/humrep/deq150. Epub 2010 Jun 22.
- Results publication: PubMed 11284660Grimbizis GF, Camus M, Tarlatzis BC, Bontis JN, Devroey P. Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update. 2001 Mar-Apr;7(2):161-74. doi: 10.1093/humupd/7.2.161.
- Results publication: PubMed 23602685Kasius JC, Eijkemans RJ, Mol BW, Fauser BC, Fatemi HM, Broekmans FJ. Cost-effectiveness of hysteroscopy screening for infertile women. Reprod Biomed Online. 2013 Jun;26(6):619-26. doi: 10.1016/j.rbmo.2013.02.015. Epub 2013 Mar 14.
- Results publication: PubMed 24286992Keats JP. Patient safety in the obstetric and gynecologic office setting. Obstet Gynecol Clin North Am. 2013 Dec;40(4):611-23. doi: 10.1016/j.ogc.2013.08.004.
- Results publication: PubMed 23053317Kilic Y, Bastu E, Ergun B. Validity and efficacy of office hysteroscopy before in vitro fertilization treatment. Arch Gynecol Obstet. 2013 Mar;287(3):577-81. doi: 10.1007/s00404-012-2584-z. Epub 2012 Oct 6.
- Results publication: PubMed 12904693Polisseni F, Bambirra EA, Camargos AF. Detection of chronic endometritis by diagnostic hysteroscopy in asymptomatic infertile patients. Gynecol Obstet Invest. 2003;55(4):205-10. doi: 10.1159/000072075.
- Results publication: PubMed 23869148Nayak PK, Mahapatra PC, Mallick J, Swain S, Mitra S, Sahoo J. Role of diagnostic hystero-laparoscopy in the evaluation of infertility: A retrospective study of 300 patients. J Hum Reprod Sci. 2013 Jan;6(1):32-4. doi: 10.4103/0974-1208.112378.
- Results publication: PubMed 22503948Ray A, Shah A, Gudi A, Homburg R. Unexplained infertility: an update and review of practice. Reprod Biomed Online. 2012 Jun;24(6):591-602. doi: 10.1016/j.rbmo.2012.02.021. Epub 2012 Mar 7.
- Results publication: PubMed 23797933Romani F, Guido M, Morciano A, Martinez D, Gaglione R, Lanzone A, Selvaggi L. The use of different size-hysteroscope in office hysteroscopy: our experience. Arch Gynecol Obstet. 2013 Dec;288(6):1355-9. doi: 10.1007/s00404-013-2932-7. Epub 2013 Jun 25.
- 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.
Amr M Al helaly, PhD study director
Ain Shams University (Obs&Gyn)
Kaled S Mohamed, PhD study chair
Ain Shams University (Obs&Gyn)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hystroscope in people with Unexplained Infertility, run by Ain Shams 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 3 Apr 2018. 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 Hanan H EL Khateeb, MS (00201008834646, drsamehhabib@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 6 months). 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 NCT03380364, which also lists 18 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 3 Apr 2018.