Unilateral vs Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate Resistant Cases of Polycystic Ovarian Syndrome

Unilateral Versus Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate (CC) Resistant Cases of Polycystic Ovarian Syndrome (PCOS): A Randomized Controlled Study

The aim of the current study is to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome in terms of clinical response (regularity of the cycle), change in biochemical parameters, ovulation rate over six months, pregnancy rate within six months.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome; Laparoscopic; Clomiphene Citrate; Unilateral; Ovarian Drilling; Bilateral
• Intervention / Treatment: Other: Unilateral laparoscopic ovarian drilling; Other: Bilateral laparoscopic ovarian drilling

Detailed Description

Polycystic ovary syndrome (PCOS), is considered the most common endocrine disorder in reproductive age in females. Polycystic ovary syndrome (PCOS) is characterized by reproductive and metabolic disturbances. Androgen excess is a hallmark of polycystic ovary syndrome (PCOS), driving many of the phenotypic features

The clinical response to laparoscopic ovarian drilling (LOD) seems to be thermal energy dose-dependent. Two punctures (300 J) per ovary are associated with poor results. Between three and five (450-750 J) punctures per ovary seem to represent the effective thermal dose. The application of six or more (C900 J) punctures per ovary may result in excessive destruction to the ovary and should therefore be discouraged.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbia
    • Tanta, ElGharbia, Egypt, 31527
      • Sahar Saeed Ahmed Elhalfawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age within 25-35 years.
• Polycystic ovarian syndrome as diagnosed according to modified Rotterdam criteria 2018: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; and transvaginal sonographic appearance of polycystic ovaries (≥ 20 follicles or an ovarian volume 10 cm3) .
• Infertile women who have clomiphene citrate -resistant polycystic ovary syndrome (150 mg/daily for 5 days for six cycles with no ovulation).
• Normal semen analysis in the husband.

Exclusion Criteria:

• Hyper-androgenic disorders like late onset congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases.
• Cushing's syndrome and androgen-secreting tumors.
• Body mass index > 30 kg/m2.
• Other medical problems like diabetes, Hypertesion, patients on steroid hormone …. etc.
• Other causes of infertility as multiple uterine fibroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Unilateral laparoscopic ovarian drilling group; Patients underwent unilateral laparoscopic ovarian drilling Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments,the type of needle was an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue. The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Unilateral: was done on the larger ovary.	Other: Unilateral laparoscopic ovarian drilling; Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments, the type of needle was an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue. The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Unilateral: was done on the larger ovary.
Other: Bilateral laparoscopic ovarian drilling group; Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments,the type of needle was e an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue. The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Bilateral : using dose adjusted according to ovarian volume.	Other: Bilateral laparoscopic ovarian drilling; Laparoscopic drilling was performed under general anesthesia as follows: 10-mm subumbilical entry and two 5-mm secondary ports in the lower part of the abdomen just above the anterior superior iliac spine. The laparoscope is introduced through the subumbilical port, and secondary ports was used for introduction of the instruments, the type of needle was an insulated unipolar needle electrode with a non-insulated distal end. We are planning to use the least thermal effective dose which is 60 J/cm3 of ovarian tissue. The number of punctures (Np) per ovary was calculated according to the following formula: N p = 60 J/cm3/40 W × 4 s, with 3 mm diameter and 4 mm depth for each puncture using power setting of 300 W for 2-4 s. Bilateral: Using dose adjusted according to ovarian volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of ovulation	Restoration of ovulation was measured before operation and for 6 month after operation .	6 month after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Folliculometry	Folliculometry was measured before operation and for 6 month after operation .	6 month after operation.
Follicle-stimulating hormone (FSH)	Follicle-stimulating hormone (FSH) was measured before operation and for 6 month after operation .	6 month after operation.
Luteinizing hormone (LH)	Luteinizing hormone (LH) was measured before operation and for 6 month after operation .	6 month after operation.
Anti-müllerian hormone(AMH)	Anti-müllerian hormone(AMH) was measured before operation and for 6 month after operation .	6 month after operation.
Pregnancy rate	Pregnancy rate was measured before operation and for 6 month after operation .	6 month after operation.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 34896/9/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data was available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No