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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Pregnancy | Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks) | 2-6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr A. Abdulreheem, MBBCh | Contact | +201006774459 | amro984@gmail.com | |
| Moustafa F Gomaa, PhD | Contact | 01226188993 |
| Name | Affiliation | Role |
|---|---|---|
| Khaled H Swaydan, PhD | Ain Shams University (Obs&Gyn) | Study Director |
| Ahmed K Mekled, PhD | Ain Shams University (Obs&Gyn) | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18492377 | Background | 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. | |
| 24365027 | Background | Pundir 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| D020702 | Hysteroscopes |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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|
| Hysteroscope | Device | 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 |
|
| 11728660 | Background | Loverro 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. |
| 22818094 | Background | Karayalcin 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. |
| 17481803 | Background | De 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. |
| 20171615 | Background | Almog 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. |
| 12798877 | Background | Barash 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. |
| 19744944 | Background | Bosteels 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. |
| 25498596 | Background | Huang 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. |
| 20091498 | Background | Hughes 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. |
| 17709558 | Background | Lea RG, Sandra O. Immunoendocrine aspects of endometrial function and implantation. Reproduction. 2007 Sep;134(3):389-404. doi: 10.1530/REP-07-0167. |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |