Back to resultsEffect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Primary Purpose
PCOS
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IVF/ICSI
Sponsored by
About this trial
This is an interventional diagnostic trial for PCOS
Eligibility Criteria
Inclusion Criteria:
- age between 25 and 35
- patients with established PCOS
- history at least one year infertility
- no response to clomiphene citrate for at least three cycles
Exclusion Criteria:
- history of previous IVF/ICSI
- chronic disease such as thyroid disorder and DM
- infertility due to sever male factor
- sever endometriosis
- infertility due to uterine factor such as multiple fibroid
- body mass index > 30
Sites / Locations
- Ain Shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PCOS women with history of LOD before IVF/ICSI
PCOS women without history of drilling
Arm Description
Outcomes
Primary Outcome Measures
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound
Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03527979
Brief Title
Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Official Title
Effect of Laparoscopic Ovarian Drilling on the Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCOS women with history of LOD before IVF/ICSI
Arm Type
Active Comparator
Arm Title
PCOS women without history of drilling
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
IVF/ICSI
Intervention Description
IVF/ICSI
Primary Outcome Measure Information:
Title
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound
Description
Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 25 and 35
patients with established PCOS
history at least one year infertility
no response to clomiphene citrate for at least three cycles
Exclusion Criteria:
history of previous IVF/ICSI
chronic disease such as thyroid disorder and DM
infertility due to sever male factor
sever endometriosis
infertility due to uterine factor such as multiple fibroid
body mass index > 30
Facility Information:
Facility Name
Ain Shams university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
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