Mild Stimulation Protocol Using Clomiphene Citrate for Women With PCOS Undergoing in Vitro Fertilization
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Infertility is of increasing significance affecting almost 48.5 million couples around the
world. Anovulation is a major cause of infertility in women with polycystic ovary syndrome
(PCOS) accounting for about 80% of women with anovulatory infertility. Ultrasound
morphological features of PCOS include the presence of 16 or more follicles measuring 2-9 mm
in diameter, and/or an overall large ovarian volume of >10mm3. Women with PCOS ultrasound
features exhibit an exaggerated response to controlled ovarian stimulation.
Controlled ovarian hyperstimulation is an established prerequisite to assisted reproductive
techniques with the aim of obtaining a higher yield of oocytes and ultimately increasing
success rates. According to the ESHRE/ASRM consensus on infertility treatment related to
polycystic ovary syndrome, IVF seems to represent a reasonable treatment option as the risks
of multiple pregnancies and ovarian hyper-stimulation syndrome may be kept to a minimum. The
optimal stimulation protocol however is still debatable. Recently, patient-friendly
stimulation protocols for assisted reproductive technology were introduced aiming at
minimizing overall treatment costs and health hazards to the patient. Mild stimulation
protocols are considered relatively novel protocols. They consist of combining oral
stimulation agents (clomiphene citrate or letrozole) with low-dose gonadotropins as effective
alternatives to conventional gonadotropin-only stimulation protocols. Mild stimulation
protocol has been associated with better tolerance, ease of use, and comparable livebirth
outcomes. The investigators aim to test the hypothesis that mild stimulation protocols could
produce a similar proportion of term livebirths to conventional treatment, while reducing
treatment costs and health hazards.
This is a prospective non-randomized controlled trial comparing a mild ovarian stimulation
protocol to conventional treatment for assisted reproductive technology at the Division of
Reproductive Endocrinology and Infertility - Haifa Idriss Fertility Center - American
University of Beirut Medical Center.