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

NCT ID: NCT04021940

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2021-07-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dose adjusted ULOD

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.

Group Type: EXPERIMENTAL

ULOD

Intervention Type: PROCEDURE

ULOD

Fixed dose ULOD

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

Group Type: ACTIVE_COMPARATOR

ULOD

Intervention Type: PROCEDURE

ULOD

Interventions

ULOD

ULOD

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hatem AbuHashim

OTHER

Sponsor Role: lead

Responsible Party

Hatem AbuHashim

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatem Abu Hashim, MD. FRCOG. PhD

Role: STUDY_CHAIR

Faculty of Medicine, Mansoura University

Eman Lotfy, MBBCh

Role: PRINCIPAL_INVESTIGATOR

New Mansoura General Hospital

Central Contacts

Hatem Abu Hashim, MD. FRCOG.PhD

Role: CONTACT

hatem_ah@hotmail.com

+20502300002

References

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.

Reference Type: BACKGROUND

PMID: 29374790 (View on PubMed)

Other Identifiers

MS.19.05.615

Identifier Type: -

Identifier Source: org_study_id