Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation

Mood Clinical Trial

Official title:

Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation: A Double-blind, Placebo-controlled, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291056
• Other study ID #: 00038807
• Status: Completed
• Phase: N/A
• First received: November 9, 2010
• Last updated: December 19, 2014
• Start date: January 2010
• Est. completion date: May 2011

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Clomiphene citrate is commonly used for ovulation induction in women with anovulation, correction of luteal phase deficiency or for superovulation as empiric therapy for unexplained infertility. Superovulation using clomiphene, usually with intrauterine insemination, is usually regarded as first line therapy for unexplained infertility, infertility due to mild endometriosis, or infertility with mild or moderate compromise of the male factor. The side effect profile reported by some women using clomiphene citrate is similar to symptoms of premenstrual dysphoric disorder (PMDD), including tension, irritability, depressed mood, affective lability, lack of energy, difficulty concentrating, and physical symptoms such as breast tenderness, bloating, headache joint and muscle pain. Few studies have been performed to examine the relationship between clomiphene citrate and mood symptoms; however, these studies have been limited by their small sample size, potential for recall bias and lack of randomization. Moreover, the experience of infertility is dysphoric in and of itself. Therefore, a rigorous evaluation of whether, when in the cycle, and how often clomiphene is associated with mood changes is needed. Such a study would add to the body of literature on this topic in three important ways: 1) use of prospective data collection to more accurately identify commonly reported symptoms, 2) characterize the timing of symptom occurrence relative to treatment cycle, and 3) provide information relevant to planning of future studies involving targeted treatment of clomiphene citrate induced symptoms. If clomiphene use is shown to affect mood, the results would point to an important avenue for psychopharmacologic insight into relationships between mood and sex steroids.

OBJECTIVES:

Specific Aim #1: To identify psychological and physical symptoms experienced by women taking clomiphene citrate for superovulation in a prospective, placebo controlled trial setting.

Specific Aim #2: To determine whether measures of the emotional and physical state prior to the administration of clomiphene, predict the occurrence of mood changes during the five days of clomiphene administration and in the late follicular and luteal phases of the cycle in which clomiphene was administered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Menstruating women, ages 25-40, with regular menstrual cycles 23-35 days in length who elect to treat unexplained infertility using clomiphene citrate for superovulation combined with intrauterine insemination will be eligible for participation in this study.

• Eligible participants will be identified by physicians at the Utah Center for Reproductive Medicine at the University of Utah and will be provided written informed consent before being randomized to treatment groups.

• Male partner's semen analysis must show a sperm density of at least 10 million per ml, and motility of 20% or greater and normal morphology using World Health Organization (WHO) criteria.

Exclusion Criteria:

• Women with a history of depression or anxiety disorder requiring hospitalization or treatment lasting more than six months and women who currently or have received treatment during the previous six months for anxiety, depression or other psychiatric disorders listed in the 4th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) will be excluded.

• Women who have previously received treatment with clomiphene citrate will also be excluded from the study.

• Women using tobacco or illicit drugs will be excluded from study participation.

• Because the measurement tool used to measure symptoms has been validated only in women who can read and speak English, women who cannot speak and read English will not be eligible to participate in the study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Mood

Intervention

Other:
• Placebo
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.

Drug:
• Clomiphene
Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calendar of Premenstrual Experiences (COPE)		1 year	No