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Combined Letrozole and Clomid in Women With Infertility and PCOS

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ClinicalTrials.gov Identifier: NCT02802865
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Rachel Mejia, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Drug: Clomiphene Drug: Letrozole Phase 4

Detailed Description:

Letrozole and Clomid are both used for ovulation induction, but they have different mechanisms of action. Letrozole has been shown to be superior to clomid in achieving live birth rates in women with infertility and polycystic ovary syndrome. However, the combination of these medications has not been studied. This is a pilot study to evaluate if the combination treatment has improved efficacy as measured by ovulation rate.

This is a randomized controlled trial of letrozole versus letrozole and clomiphene citrate (CC) for one menstrual cycle. Women will be randomized in a 1:1 ratio to receive letrozole 2.5 mg or combination of letrozole 2.5 mg and clomiphene 50 mg for 5 days on days 3-7 of menstrual cycle. The women and their partners will be instructed to have regular intercourse with the intent to conceive during the cycle. Patients will have an transvaginal ultrasound mid cycle and to evaluate number of follicles (>15 mm), follicle size, endometrial thickness and pattern. Patients will have mid- luteal phase progesterone level drawn to evaluate ovulation. Side effect profile will also be monitored.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Letrozole and Clomid in Polycystic Ovary Syndrome: a Randomized Control Trial of Combination of Letrozole and Clomiphene Citrate or Letrozole Alone for the Treatment of Infertility in Women With Polycystic Ovary Syndrome
Study Start Date : August 2016
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Letrozole
Letrozole 2.5 mg orally for 5 days on cycle days 3-7
Drug: Letrozole
Other Name: femara

Experimental: Letrozole + Clomiphene
Letrozole 2.5 mg orally for 5 days on cycle days 3-7 AND Clomid 50 mg orally for 5 days on cycle days 3-7
Drug: Clomiphene
Other Names:
  • clomid
  • clomiphene citrate

Drug: Letrozole
Other Name: femara




Primary Outcome Measures :
  1. ovulation [ Time Frame: The primary outcome of ovulation will be measured by a mid-luteal phase progesterone level. This will occur 7 days following LH surge or at cycle day 21 if no LH surge was detected. This will be assessed once during the cycle/study period. ]
    ovulation measured by mid-luteal progesterone (>3 ng/mL)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802865


Locations
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Rachel Mejia
Investigators
Principal Investigator: Rachel Mejia, DO University of Iowa Hosptials & Clinics
Principal Investigator: Brad Van Voorhis, MD University of Iowa Hospitals & Clinics

Responsible Party: Rachel Mejia, Associate Fellow, University of Iowa
ClinicalTrials.gov Identifier: NCT02802865     History of Changes
Other Study ID Numbers: 201606806
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists