Female Reproductive Problem Clinical Trial
Official title:
Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged
women and affects approximately 5-12 % of the female population.
In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected
individuals must have two out of the following three criteria:
1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).
2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank
virilization, while chemical indicators include raised concentrations of total
testosterone and androstenedione , and elevated free androgen index.
3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in
either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3
and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic
criteria, the majority of women with PCOS can be diagnosed without the need of
laboratory examinations.
Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation.
It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the
latter being the more potent of the two. It is a non-steroidal compound closely resembling
estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby
signaling a lack of circulating estrogens and inducing a change in the pulsatile release of
gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone
from the anterior pituitary and is often enough to set the cycle of events leading to
ovulation into motion.
Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective
prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg,
which could be increased, if needed, to twice a week. This medicine has slight dopamine
agonistic side effects, headache being the most common one. Treatment in the very beginning
should start with a partial dose (half a pill) at bedtime with a small amount of food. Low
incidence of side effects and its weekly dose has made Cabergoline a choice drug for
treatment of related diseases.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02249390 -
Assisted Reproductive Technology Survey (ART Survey)
|
||
| Unknown status |
NCT02213627 -
Use of Corifolitropin Alfa in Oocyte Donors
|
Phase 4 | |
| Terminated |
NCT02377219 -
Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.
|
N/A | |
| Completed |
NCT03617354 -
The Implementation of MinimAlly Invasive Hysterectomy Trial
|