Status:
UNKNOWN
Cost Effectiveness Analysis for Induction of Ovulation in the Polycystic Ovary Syndrome by Letrozole Versus Clomiphene Citrate
Lead Sponsor:
Assiut University
Conditions:
Infertility
Eligibility:
FEMALE
18-35 years
Phase:
EARLY_PHASE1
Brief Summary
To evaluate cost effectiveness of Letrozole versus clomiphene citrate (CC) in induction of ovulation in patients with polycystic ovary syndrome.
Detailed Description
Polycystic ovary syndrome (PCOS) is a common cause of infertility that affects 4% - 8% of reproductive-age females (Priya,M.R,2019). Diagnosis of PCOS is very important for proper management. In lite...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Women with infertility secondary to PCOS according to ESHRE/ASRM (Rotterdam criteria) 2004. Patients have at least two of the following; clinical and/or biochemical hyperandrogenism, oligo-ovulation or anovulation, polycystic ovaries by sonography (Diagnosis of oligo-/anovulation will be based on a menstrual pattern of oligo-/amenorrhoea (cycle \>35 days) and/or a low mid-luteal serum progesterone concentration. Hyperandrogenaemia will be diagnosed either clinically (acne/hirsutism) or biochemically (testosterone ≥2.5 nmol/l or free androgen index \[FAI\] ≥5). Ultrasound criteria will include ≥12 follicles (2-9 mm) and/or an ovarian volume of \>10 ml).
- Age between 18 to 35 years with Body Mass Index (BMI) not more than 35 kg/m2, free of any medical disease and not receiving medications in the last 3 months.
- Exclusion criteria:
- Patients with other causes of infertility, gross ovarian pathology diagnosed by ultrasound, previous tubal or ovarian surgery or laparoscopic ovarian drilling will be excluded from the study.
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04361175
Start Date
March 1 2021
End Date
December 1 2021
Last Update
January 20 2021
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