Laparoscopic Ovarian Drilling and Subendometrial Blood Flow
NCT03334955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2017-11-07
Summary
Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days 2-4 of this withdrawal bleeding.
Color Doppler ultrasound scanning will be performed to assess the subendometrial blood flow. The subendometrial region was observed and analyzed in each woman using color and power Doppler flow ultrasonography. By means of color and power Doppler flow imaging, color signals was searched for in the subendometrial region and areas of maximum color intensity, representing the greatest Doppler frequency shifts, was visualized, then selected for pulsed Doppler examination. Pulsatility index (PI) and resistance index (RI) were calculated in each selected Doppler wave.
Laparoscopic ovarian drilling was performed under general anesthesia with good muscle relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular phase (after stoppage of menstrual or withdrawal bleeding).
A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml crystalloid solution before releasing the ligament.
Follow up:
Total testosterone and blood flow assessment (PI - RI) of the subendometrial region were performed again in the early follicular phase (days 2-4 of the menstrual cycle) of the first post-operative spontaneous menstruation (which occurred within 10 weeks after the operation).
Also, patients were followed to detect ovulation. ovulating patients were followed for 6 months to detect pregnancy.
Conditions
- Polycystic Ovary Syndrome
Interventions
- PROCEDURE
-
Laparoscopic ovarian drilling
A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points, with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds.
Sponsors & Collaborators
-
Zagazig University
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 34 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-15
- Primary Completion
- 2017-03-15
- Completion
- 2017-10-30
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