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Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women (ESLOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140398
Recruitment Status : Unknown
Verified May 2014 by Ahmed Gibreel, Mansoura University.
Recruitment status was:  Recruiting
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Ahmed Gibreel, Mansoura University

Brief Summary:
Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.

Condition or disease Intervention/treatment Phase
Infertility Polycystic Ovarian Syndrome Procedure: Endometrial Currettage Phase 4

Detailed Description:
Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
Study Start Date : April 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Currettage
Endometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Procedure: Endometrial Currettage
Only Laparoscopic ovarian drilling without endometrial currettage will be performed
Other Names:
  • Endometrial injury
  • endometrial scratching
  • Endometrial scraping

No Intervention: Nothing
No endometrial curettage at time of Laparoscopic ovarian drilling



Primary Outcome Measures :
  1. live birth rate per woman randomized [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. pregnancy rate per woman randomised [ Time Frame: 6 months ]

Other Outcome Measures:
  1. miscarriage rate time to pregnancy interval [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
  2. Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
  3. Patent Fallopian tubes as confirmed by hysterosalpingography
  4. Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).

Exclusion Criteria:

  1. women with BMI >30,
  2. age < 18 years or > 39 years,
  3. women with ovarian cysts identified by transvaginal ultrasound
  4. male factor infertility
  5. Tubal factor infertility as suggested by hystrosalpingogram (HSG)
  6. Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140398


Contacts
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Contact: Ahmed Gibreel, MD 00201004045733 ahmedfathgi@yahoo.com

Locations
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Egypt
Mansoura University Teaching Hospital Recruiting
Mansoura, Egypt, 53111
Principal Investigator: Ahmed Gibreel, MD         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed Gibreel, MD Mansoura University

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Responsible Party: Ahmed Gibreel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02140398    
Other Study ID Numbers: 92013
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Ahmed Gibreel, Mansoura University:
infertility
PCOS
scratching
endometrial receptivity
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Infertility
Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases