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

NCT ID: NCT06537102

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-06-01

Brief Summary

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.

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.

Conditions

Laparoscopic; Ovarian Drilling; Clomiphene Citrate; Polycystic Ovarian Syndrome; Unilateral; Bilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Unilateral laparoscopic ovarian drilling

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Bilateral laparoscopic ovarian drilling

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Saeed Ahmed Elhalfawy

Resident of Obstetrics and Gynecology department, Ebiar central hospital, Faculty of Medicine, University of Tanta, Tanta, AL Gharbia ,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sahar Saeed Ahmed Elhalfawy

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

34896/9/21

Identifier Type: -

Identifier Source: org_study_id