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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
Hatem AbuHashim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 13, 2019
    Last Updated
    July 16, 2019
    Sponsor
    Hatem AbuHashim
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    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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