Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women
ESLOD
Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 16, 2014
May 1, 2014
1.4 years
April 25, 2014
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
live birth rate per woman randomized
15 months
Secondary Outcomes (1)
pregnancy rate per woman randomised
6 months
Other Outcomes (1)
miscarriage rate time to pregnancy interval
6 months
Study Arms (2)
Currettage
EXPERIMENTALEndometrial Currettage (endometrial scrapping) will be performed at the time of laparoscopic ovarian drilling
Nothing
NO INTERVENTIONNo endometrial curettage at time of Laparoscopic ovarian drilling
Interventions
Only Laparoscopic ovarian drilling without endometrial currettage will be performed
Eligibility Criteria
You may qualify if:
- subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
- Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
- Patent Fallopian tubes as confirmed by hysterosalpingography
- Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).
You may not qualify if:
- women with BMI \>30,
- age \< 18 years or \> 39 years,
- women with ovarian cysts identified by transvaginal ultrasound
- male factor infertility
- Tubal factor infertility as suggested by hystrosalpingogram (HSG)
- Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Teaching Hospital
Al Mansurah, 53111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Gibreel, MD
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 25, 2014
First Posted
May 16, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
May 16, 2014
Record last verified: 2014-05