Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients

NCT04021940 | Unknown

• 1 other identifier: MS.19.05.615
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• ovulation rate

  serum progesterone level \>5 ng/mL on D 21 of the cycle

  At 6 months postoperative

Study Arms (2)

Dose adjusted ULOD

EXPERIMENTAL

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.

Procedure: ULOD

Fixed dose ULOD

ACTIVE COMPARATOR

600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W

Procedure: ULOD

Interventions

ULOD PROCEDURE

ULOD

Dose adjusted ULOD; Fixed dose ULOD

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatem AbuHashim: lead

Related Publications (1)

• 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.

  PMID: 29374790 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Hatem Abu Hashim, MD. FRCOG. PhD

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Eman Lotfy, MBBCh

  New Mansoura General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatem Abu Hashim, MD. FRCOG.PhD

CONTACT

+20502300002; hatem_ah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: August 5, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 30, 2021
• Last Updated: July 19, 2019

Record last verified: 2019-07