Combined Letrozole and Clomid in Women With Infertility and PCOS
Condition: Polycystic Ovary Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Intervention: Clomiphene; Letrozole
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This study evaluates the addition of clomid to letrozole for the treatment of infertility in
      women with polycystic ovary syndrome. Half of the participants will receive letrozole and
      clomid in combination, while the other half will receive letrozole alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to comply with all study procedures and be available for the duration of the
             study

          2. Diagnosis of infertility: Inability of couple to achieve successful pregnancy after 12
             months of regular timed unprotected intercourse in women less than 35 years of age;
             and after 6 months of regular intercourse without use of contraception in women 35
             years and older

          3. Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria

          4. Ability to have regular intercourse during the ovulation induction phase of the study

          5. Normal sperm concentration of 15 million/mL and with normal motility of > 40%
             according to World Health Organization cutoff points, in at least one ejaculate during
             the previous year

        Exclusion Criteria:

          1. Current pregnancy

          2. Current use of hormonal contraception; use of any type of combined contraceptive or
             oral progestins within the past month; or use of hormonal implants or depo progestins
             within the past 3 months

          3. Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities

          4. Uncorrected thyroid disease

          5. Untreated hyperprolactinemia.

          6. Medical conditions in which avoiding pregnancy is recommended until under improved
             control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension

          7. Contraindications to clomiphene citrate: hypersensitivity to CC or any of its
             components, history of liver disease or known liver disease, unknown cause of abnormal
             uterine bleeding, or intracranial lesion

          8. Contraindications to letrozole: hypersensitivity to letrozole or any of its
             components.

          9. Use of medications known to affect reproductive function or metabolism or that are an
             absolute contraindication during pregnancy within the past month.

         10. If patients are suspected based on clinical findings for other etiologies that mimic
             PCOS, work up must be completed to exclude other etiologies prior to enrollment (i.e.
             Cushing's syndrome, androgen-secreting tumor).