Status:
COMPLETED
Laparoscopic Ovarian Drilling and Subendometrial Blood Flow
Lead Sponsor:
Zagazig University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-34 years
Phase:
NA
Brief 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 p...
Detailed Description
Effect of Laparoscopic Ovarian Drilling on Subendometrial Blood Flow in Women with Polycystic Ovary Syndrome Patients and methods: This interventional study was carried out in the Department of Obst...
Eligibility Criteria
Inclusion
- Patients' ages 20 to 34 years.
- BMI 18-25 kg/m2.
- PCOS was diagnosed according to Rotterdam criteria, 2003 (two criteria are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three criteria of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant).
- Hysterosalpingography and husband semen analysis were normal in all subjects.
- All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate.
Exclusion
- Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities.
- Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy.
- Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility.
- Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions.
- Previous uterine, tubal or ovarian surgery.
- Contraindications to laparoscopy and general anesthesia.
- Pregnancy before the first post-operative menstrual cycle.
Key Trial Info
Start Date :
July 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03334955
Start Date
July 15 2016
End Date
October 30 2017
Last Update
November 7 2017
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