Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation

NCT01291056 | Completed Results DMC

• 1 other identifier: 00038807
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood

Keywords

Clomiphene citrate; Mood symptoms; Infertility; Superovulation; Effects of clomiphene on mood

Outcome Measures

Primary Outcomes (4)

• Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

  To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

  1 year

• Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

  To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

  1 Year

• Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

  To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

  1 year

• Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment

  To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.

  1 year

Study Arms (2)

Clomphine

ACTIVE COMPARATOR

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

Drug: Clomiphene

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

Clomiphene DRUG

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

Clomphine

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Jessica Pittman
• Organization: University of Utah Department of Obstetrics & Gynecology

jessica.pittman@hsc.utah.edu

801-339-4103

Study Officials

• Jessica Pittman, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: February 7, 2011
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 28, 2016
• Results First Posted: June 28, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)