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Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility

Primary Purpose

Unexplained Infertility

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Endometrial scratching
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility focused on measuring endometrial scratching, pipelle, pregnancy rate, unexplained infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria 1. Women diagnosed to have unexplained infertility aged between 20-35y.

2. Regular menstruation with the length of the cycle between 21-35 days. 3. Ovulation confirmed by appropriately timed mid-luteal progesterone. 4. Fertile semen variables (according to world health organization criteria 2010).

5. Bilateral tubal patency (demonstrated by laparoscopy or hystrosalpingography).

Exclusion Criteria: 1- Patients aged less than 20 y. or more than 35y 2- Infertile semen analysis. 3- Abnormal hormonal profile (FSH level more than 10). 4- Patient diagnosed as polycystic ovary (PCO). 5- Medical disorders as hypertention,liver and renal diseases. 6- Endocrinal disorders as hyperthyroidism,hypothyroidism and diabetes mellitus.

7- Pelvic pathology as PID or uterine fibroids. 8- No previous history or planning for IVF. 9- Unwilling to comply with the protocol. 10- Participation in another clinical trial in the last 3 months prior to the start of this study.

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Sites / Locations

  • Ain Shams Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Endometrial scraching of uterine cavity by pipelle .

Uterine sound intoduced into uterine cavity without scratch .

Outcomes

Primary Outcome Measures

Biochemical Pregnancy Rate in Scratching and Non Endometrial Scratching Group.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2014
Last Updated
March 10, 2014
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02084914
Brief Title
Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility
Official Title
The Effect of Endometrial Scratching by Pipelle on Pregnancy Rate in Couples With Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Research question: Population: women with unexplained infertility. Intervention: endometrial scratching by pipelle for women with unexplained infertility. Comparison: to compare with non endometrial scratching for women with unexplained infertility. Outcome: the biochemical pregnancy rate. Research hypothesis: Null hypothesis: there is no difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility. Alternative hypothesis: there is difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility.
Detailed Description
Unexplained infertility (UI) is a term used to describe infertile couples in whom standard investigations, including semen analysis, tests of ovulation and tubal patency, have failed to detect any gross abnormality (Crosignani et al., 1993). It is a diagnosis of exclusion, almost 30-40% of infertile couples would suffer from this type of subfertility (Simth et al., 2003). A diversity of causes had been hypothesized to explain the condition. Cervical, uterine, ovulatory, peritoneal, immunological, endocrinological, genetic defects and reproductive physiology disturbances had been continuously suggested as potential causative factors (Rov et al., 2005; Shveiky et al., 2006; Bellver et al., 2008; Golubovsky, 2008; Woodson, 2008). Empirically, interventions for managing unexplained infertility had been widely practiced. These interventions include expectant management, intrauterine insemination (IUI) with ovarian stimulation and in vitro fertilization (El-Toukhy & Khalaf, 2008; Bhattachary et al., 2010). In humans, the uterus becomes receptive during the midsecretory phase of the menstrual cycle (days 19-23), commonly known as the window of implantation (WOI). It is assumed that inadequate uterine receptivity is responsible for approximately two-thirds of implantation failures (Simon et al., 1998). Since an impairment of endometrial receptivity may be a cause of subfertility in a group of couples diagnosed with unexplained infertility (Jasper et al., 2006; Boroujerdnia & Nikbakht, 2008; Konac et al., 2009). Endometrial scratching may help a group of couples with unexplained infertility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility
Keywords
endometrial scratching, pipelle, pregnancy rate, unexplained infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Endometrial scraching of uterine cavity by pipelle .
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Uterine sound intoduced into uterine cavity without scratch .
Intervention Type
Procedure
Intervention Name(s)
Endometrial scratching
Other Intervention Name(s)
Unexplained Infertility
Intervention Description
Group A: pipelle Group B: sound
Primary Outcome Measure Information:
Title
Biochemical Pregnancy Rate in Scratching and Non Endometrial Scratching Group.
Time Frame
six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 1. Women diagnosed to have unexplained infertility aged between 20-35y. 2. Regular menstruation with the length of the cycle between 21-35 days. 3. Ovulation confirmed by appropriately timed mid-luteal progesterone. 4. Fertile semen variables (according to world health organization criteria 2010). 5. Bilateral tubal patency (demonstrated by laparoscopy or hystrosalpingography). Exclusion Criteria: 1- Patients aged less than 20 y. or more than 35y 2- Infertile semen analysis. 3- Abnormal hormonal profile (FSH level more than 10). 4- Patient diagnosed as polycystic ovary (PCO). 5- Medical disorders as hypertention,liver and renal diseases. 6- Endocrinal disorders as hyperthyroidism,hypothyroidism and diabetes mellitus. 7- Pelvic pathology as PID or uterine fibroids. 8- No previous history or planning for IVF. 9- Unwilling to comply with the protocol. 10- Participation in another clinical trial in the last 3 months prior to the start of this study. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anhar mohamed Ali Shehata, M.B.B.Ch
Phone
01005764423
Ext
01115959740
Email
doc_anhar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed E Elbohoty, MD
Organizational Affiliation
OB GYN Department, faculty of Medicine, ASU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed E Elbohoty, MD
Email
elbohoty79@yahoo.com

12. IPD Sharing Statement

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Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility

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