Status:
ACTIVE_NOT_RECRUITING
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
Lead Sponsor:
Rachel Mejia
Collaborating Sponsors:
Society for Reproductive Investigation
American Society for Reproductive Medicine
Conditions:
Polycystic Ovary Syndrome
PCOS
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair st...
Detailed Description
Letrozole and Clomid are both used for ovulation induction, but they have different mechanisms of action. In a pilot study we found that the combination of letrozole 2.5 mg and CC 50 mg nearly doubled...
Eligibility Criteria
Inclusion
- Willing to comply with all study procedures and be available for the duration of the study
- Diagnosis of infertility: Inability of couple to achieve successful pregnancy after 12 months of regular time 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. Women that have anovulation or oligomenorrhea are also considered to meet diagnosis of infertility, without meeting the time constraints described above.
- Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria.
- Ability to have regular intercourse during the ovulation induction phase of the study.
- Partner with a normal sperm concentration of 15 million/mL and with normal motility of \>40% according to World Health Organization cutoff points or greater than 10 million total motile sperm count OR has fathered a pregnancy in the past.
Exclusion
- Current pregnancy
- 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
- Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities
- Uncorrected thyroid disease
- Untreated hyperprolactinemia
- Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension
- Contraindications to clomiphene citrate: hypersensitivity to clomiphene citrate or any of its components, history of liver disease or known liver disease, unknown cause of abnormal uterine bleeding, or intracranial lesion
- Contraindications to letrozole: hypersensitivity to letrozole or any of its components
- Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month
- 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)
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05206448
Start Date
October 26 2020
End Date
December 1 2025
Last Update
April 15 2025
Active Locations (4)
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1
University of Iowa Hospitals & Clinics - Davenport Clinic
Davenport, Iowa, United States, 52807
2
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
3
University of Iowa Hospitals & Clinics- West Des Moines Clinic
West Des Moines, Iowa, United States, 50266
4
University of Wisconsin
Madison, Wisconsin, United States, 53562