An interventional study of Unilateral laparoscopic ovarian drilling and Bilateral laparoscopic ovarian drilling in Laparoscopic, Ovarian Drilling and Clomiphene Citrate, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 130 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
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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 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. Unilateral: was done on the larger ovary.
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.
Restoration of ovulation
Restoration of ovulation was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Folliculometry
Folliculometry was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Follicle-stimulating hormone (FSH)
Follicle-stimulating hormone (FSH) was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Luteinizing hormone (LH)
Luteinizing hormone (LH) was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Anti-müllerian hormone(AMH)
Anti-müllerian hormone(AMH) was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Pregnancy rate
Pregnancy rate was measured before operation and for 6 month after operation .
Time frame: 6 month after operation.
Plan to share: Yes — The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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