Uterine Scratching in Intra-Uterine Insemination
Primary Purpose
Infertility, Unexplained Infertility
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endometrial scratching
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring intra-uterine insemination, endometrial injury, scratching
Eligibility Criteria
Inclusion Criteria:
- Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above.
- At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years.
- Antral follicular count over 5.
- Normal or mild male factor.
- Normal uterine cavity.
- An IUI prescription.
Exclusion Criteria:
- Polycystic ovary syndrome with irregular menstrual cycles over 45 days
- Severe endometriosis
- IUI with Donor sperm
- Patient with invasive intra-uterine procedure in the last 3 months.
- Contraindication to endometrial biopsy.
Sites / Locations
- Clinique Ovo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Endometrial scratching group
Control group
Arm Description
Endometrial scratching will be done with a Pipelle in uterus.
This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure
Outcomes
Primary Outcome Measures
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.
Secondary Outcome Measures
Efficacy - Secondary pregnancy rate.
Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching
Safety - Side effects
Evaluate side effects related to the intrauterine scratching
Safety - Complications
Evaluate complications related to intrauterine scratching
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03828786
Brief Title
Uterine Scratching in Intra-Uterine Insemination
Official Title
The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Ovo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.
Detailed Description
Infertility is defined as the absence of conception after a year of unprotected intercourse. In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. This is done by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF and has been shown beneficial. Theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. However, there is very few data concerning scratching in intrauterine insemination. The studies are mostly small studies and the results are often contradictory. In this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Unexplained Infertility
Keywords
intra-uterine insemination, endometrial injury, scratching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial scratching group
Arm Type
Active Comparator
Arm Description
Endometrial scratching will be done with a Pipelle in uterus.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure
Intervention Type
Procedure
Intervention Name(s)
Endometrial scratching
Other Intervention Name(s)
Endometrial Biopsy
Intervention Description
Endometrial Biopsy by aspiration with a pipelle
Primary Outcome Measure Information:
Title
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
Description
Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Efficacy - Secondary pregnancy rate.
Description
Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching
Time Frame
6 months
Title
Safety - Side effects
Description
Evaluate side effects related to the intrauterine scratching
Time Frame
6 months for all 3 intrauterine insemination
Title
Safety - Complications
Description
Evaluate complications related to intrauterine scratching
Time Frame
6 months for all 3 intrauterine insemination
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women of reproductive age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above.
At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years.
Antral follicular count over 5.
Normal or mild male factor.
Normal uterine cavity.
An IUI prescription.
Exclusion Criteria:
Polycystic ovary syndrome with irregular menstrual cycles over 45 days
Severe endometriosis
IUI with Donor sperm
Patient with invasive intra-uterine procedure in the last 3 months.
Contraindication to endometrial biopsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Lapensee, Md
Organizational Affiliation
Clinique Ovo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Ovo
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17681303
Citation
Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
Results Reference
background
PubMed Identifier
26538858
Citation
Wadhwa L, Pritam A, Gupta T, Gupta S, Arora S, Chandoke R. Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle. J Hum Reprod Sci. 2015 Jul-Sep;8(3):151-8. doi: 10.4103/0974-1208.165144.
Results Reference
background
PubMed Identifier
17197286
Citation
Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
Results Reference
background
PubMed Identifier
23095139
Citation
Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.
Results Reference
background
PubMed Identifier
22786529
Citation
Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.
Results Reference
background
PubMed Identifier
20607003
Citation
Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
Results Reference
background
PubMed Identifier
26342054
Citation
Maged AM, Al-Inany H, Salama KM, Souidan II, Abo Ragab HM, Elnassery N. Endometrial Scratch Injury Induces Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation: A Randomized Controlled Trial. Reprod Sci. 2016 Feb;23(2):239-43. doi: 10.1177/1933719115602776. Epub 2015 Sep 3.
Results Reference
background
PubMed Identifier
27296541
Citation
Lensen SF, Manders M, Nastri CO, Gibreel A, Martins WP, Templer GE, Farquhar C. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD011424. doi: 10.1002/14651858.CD011424.pub2.
Results Reference
background
PubMed Identifier
27008891
Citation
Lensen S, Sadler L, Farquhar C. Endometrial scratching for subfertility: everyone's doing it. Hum Reprod. 2016 Jun;31(6):1241-4. doi: 10.1093/humrep/dew053. Epub 2016 Mar 22.
Results Reference
background
PubMed Identifier
26777262
Citation
Ledee N, Petitbarat M, Chevrier L, Vitoux D, Vezmar K, Rahmati M, Dubanchet S, Gahery H, Bensussan A, Chaouat G. The Uterine Immune Profile May Help Women With Repeated Unexplained Embryo Implantation Failure After In Vitro Fertilization. Am J Reprod Immunol. 2016 Mar;75(3):388-401. doi: 10.1111/aji.12483. Epub 2016 Jan 18.
Results Reference
background
PubMed Identifier
20070722
Citation
Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
Results Reference
background
PubMed Identifier
23106834
Citation
Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29. Erratum In: J Obstet Gynaecol Res. 2021 Aug;47(8):2936.
Results Reference
background
PubMed Identifier
5050152
Citation
Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.
Results Reference
background
PubMed Identifier
12798877
Citation
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.
Results Reference
background
PubMed Identifier
27146582
Citation
Bahaa Eldin AM, Abdelmaabud KH, Laban M, Hassanin AS, Tharwat AA, Aly TR, Elbohoty AE, Elsayed HM, Ibrahim AM, Ibrahim ME, Sabaa HM, Abdelrazik AA, Abdelhady I. Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial. Reprod Sci. 2016 Oct;23(10):1326-31. doi: 10.1177/1933719116638191. Epub 2016 May 4.
Results Reference
background
PubMed Identifier
23494199
Citation
Abdelhamid AM. The success rate of pregnancy in IUI cycles following endometrial sampling. A randomized controlled study: endometrial sampling and pregnancy rates. Arch Gynecol Obstet. 2013 Sep;288(3):673-8. doi: 10.1007/s00404-013-2785-0. Epub 2013 Mar 15.
Results Reference
background
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Uterine Scratching in Intra-Uterine Insemination
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