Combined Letrozole and Clomid in Women With Infertility and PCOS

NCT02802865 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201606806
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Infertility

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level

  Ovulation: mid-luteal progesterone \> /=3 ng/mL. No ovulation: mid-luteal progesterone \<3ng/mL.

  7 days following LH surge or at cycle day 21 if no LH surge was detected

Secondary Outcomes (8)

• Number of Developing Follicles

  Cycle day 12-14

• Size of Largest Developing Follicle

  Cycle day 12-14

• Endometrial Thickness

  Cycle day 12-14

• Conception

  5 weeks after treatment

• Clinical Pregnancy

  6-7 weeks after treatment

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

Letrozole 2.5 mg orally for 5 days on cycle days 3-7

Drug: Letrozole

Letrozole + Clomiphene

EXPERIMENTAL

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; Drug: Letrozole

Interventions

Clomiphene DRUG

Also known as: clomid, clomiphene citrate

Letrozole + Clomiphene

Letrozole DRUG

Also known as: femara

Letrozole; Letrozole + Clomiphene

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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
• Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria
• Ability to have regular intercourse during the ovulation induction phase of the study
• 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

You may not qualify if:

• 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 CC 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).

Sponsors & Collaborators

• Rachel Mejia: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• Mejia RB, Summers KM, Kresowik JD, Van Voorhis BJ. A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2019 Mar;111(3):571-578.e1. doi: 10.1016/j.fertnstert.2018.11.030. Epub 2019 Jan 22.

  PMID: 30683591 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Clomiphene; Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was powered to detect a difference in ovulation rate between the treatment arms. The study was underpowered to detect significant between-group differences for conception, pregnancy, pregnancy loss, and live birth.

Results Point of Contact

• Title: Dr. Rachel Mejia
• Organization: University of Iowa

rachel-mejia@uiowa.edu

319-356-3143

Study Officials

• Rachel Mejia, DO

  University of Iowa Hosptials & Clinics

  PRINCIPAL INVESTIGATOR

• Brad Van Voorhis, MD

  University of Iowa Hospitals & Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Fellow

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)