Status:
UNKNOWN
Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in PCOS Patients
Lead Sponsor:
Hatem AbuHashim
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-34 years
Phase:
NA
Brief Summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is cons...
Eligibility Criteria
Inclusion
- Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
- CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
- Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
- Age: 20-34 years.
- Body mass index \< 30 kg/m2
- Patent fallopian tubes by hysterosalpingography.
- Normal semen analysis of husbands.
Exclusion
- Age ≥ 35 years.
- BMI ≥ 30
- Previous history of LOD
- PCOS phenotypes with regular menses or without PCOM ovaries on USS.
- Other causes of infertility
- Women with adrenal hyperplasia, thyroid disease, Cushing's syndrome, hyperprolactinemia and a tumor-related excess of androgen.
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04021940
Start Date
August 5 2019
End Date
July 30 2021
Last Update
July 19 2019
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