Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ULOD
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
- CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
- Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
- Age: 20-34 years.
- Body mass index < 30 kg/m2
- Patent fallopian tubes by hysterosalpingography.
- Normal semen analysis of husbands.
Exclusion Criteria:
- Age ≥ 35 years.
- BMI ≥ 30
- Previous history of LOD
- PCOS phenotypes with regular menses or without PCOM ovaries on USS.
- Other causes of infertility
- Women with adrenal hyperplasia, thyroid disease, Cushing's syndrome, hyperprolactinemia and a tumor-related excess of androgen.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dose adjusted ULOD
Fixed dose ULOD
Arm Description
dose adjusted ULOD using 60J/cm3 applied to the larger ovary. The number of punctures (Np) per ovary will be calculated according to the following formula: Np = 60 J/cm3 divided by 30 W x 4 s.
600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W
Outcomes
Primary Outcome Measures
ovulation rate
serum progesterone level >5 ng/mL on D 21 of the cycle
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04021940
Brief Title
Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients
Official Title
A Randomized Comparison of Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hatem AbuHashim
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
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is considered a second-line treatment of infertile patients with clomiphene citrate-resistant (CCR) PCOS i.e. those who did not ovulate in response to CC doses of up to 150 mg for at least three consecutive cycles. The advantage of LOD is the induction of unifollicular ovulation without the risk of ovarian hyperstimulation syndrome or high-order multiple pregnancies.
The common practice of LOD was to drill both ovaries i.e. bilateral (BLOD) with a fixed dose of 600 Joules per each ovary (1200 Joules in both) delivered through four punctures, each for 4 s and using 40 W. However, its main adverse effect is diminished ovary reserve due to tissue damage (2). In 1994, Balen and Jacobs reported the effectiveness of fixed-dose unilateral LOD (ULOD) in the management of those women. Subsequently, several randomized trials demonstrated its efficacy with comparable ovulation and pregnancy rates to BLOD.
Recently, a new concept called"dose-adjusted" ULOD was proposed. It means to tailor the energy applied to one ovary, according to its preoperative volume using 60 J/ cm3. When compared with the fixed-dose BLOD among 96 infertile women with CCR- PCOS, a significantly higher ovulation rate during the first postoperative menstrual cycle was in favor of the ULOD group (73 vs. 49%). Meanwhile, a comparable ovulation rate over the 6-month period was found (82 vs. 64%) (6). In addition, both groups experienced a reduction in serum anti-mullerian hormone (AMH) level after LOD which was significantly more in the BLOD group in the first and the 6-month follow-up periods. However, another RCT (n=108 CCR- PCOS patients) reported a comparable ovulation and pregnancy rates at 3-month follow-up period (65.4 vs. 77.3% and 15.4 vs. 26.4%, in ULOD and BLOD respectively) with a reduction in the effectiveness of dose-adjusted ULOD after 6 months. A highly significant difference between ULOD and BLOD groups with regard to the AMH level at 3- and 6-month was also reported. Thereby, the efficacy of dose-adjusted ULOD in improving fertility outcomes in infertile women with CCR- PCOS as well as its effect on ovarian reserve warrants more investigation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose adjusted ULOD
Arm Type
Experimental
Arm Description
dose adjusted ULOD using 60J/cm3 applied to the larger ovary. The number of punctures (Np) per ovary will be calculated according to the following formula: Np = 60 J/cm3 divided by 30 W x 4 s.
Arm Title
Fixed dose ULOD
Arm Type
Active Comparator
Arm Description
600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W
Intervention Type
Procedure
Intervention Name(s)
ULOD
Intervention Description
ULOD
Primary Outcome Measure Information:
Title
ovulation rate
Description
serum progesterone level >5 ng/mL on D 21 of the cycle
Time Frame
At 6 months postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
Age: 20-34 years.
Body mass index < 30 kg/m2
Patent fallopian tubes by hysterosalpingography.
Normal semen analysis of husbands.
Exclusion Criteria:
Age ≥ 35 years.
BMI ≥ 30
Previous history of LOD
PCOS phenotypes with regular menses or without PCOM ovaries on USS.
Other causes of infertility
Women with adrenal hyperplasia, thyroid disease, Cushing's syndrome, hyperprolactinemia and a tumor-related excess of androgen.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hatem Abu Hashim, MD. FRCOG.PhD
Phone
+20502300002
Email
hatem_ah@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. FRCOG. PhD
Organizational Affiliation
Faculty of Medicine, Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eman Lotfy, MBBCh
Organizational Affiliation
New Mansoura General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29374790
Citation
Abu Hashim H, Foda O, El Rakhawy M. Unilateral or bilateral laparoscopic ovarian drilling in polycystic ovary syndrome: a meta-analysis of randomized trials. Arch Gynecol Obstet. 2018 Apr;297(4):859-870. doi: 10.1007/s00404-018-4680-1. Epub 2018 Jan 27.
Results Reference
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Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients
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