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

NCT06537102 | Completed

• 1 other identifier: 34896/9/21
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Restoration of ovulation

  Restoration of ovulation was measured before operation and for 6 month after operation .

  6 month after operation.

Secondary Outcomes (5)

• Folliculometry

  6 month after operation.

• Follicle-stimulating hormone (FSH)

  6 month after operation.

• Luteinizing hormone (LH)

  6 month after operation.

• Anti-müllerian hormone(AMH)

  6 month after operation.

• Pregnancy rate

  6 month after operation.

Study Arms (2)

Unilateral laparoscopic ovarian drilling group

OTHER

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

Bilateral laparoscopic ovarian drilling group

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 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

Interventions

Unilateral laparoscopic ovarian drilling 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.

Unilateral laparoscopic ovarian drilling group

Bilateral laparoscopic ovarian drilling 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.

Bilateral laparoscopic ovarian drilling group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Females with Polycystic Ovarian Syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Sahar Saeed Ahmed Elhalfawy

Tanta, ElGharbia, 31527, Egypt

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology department, Ebiar central hospital, Faculty of Medicine, University of Tanta, Tanta, AL Gharbia ,

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author

Locations

EG (1)