Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
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.