Fertility Centers of Illinois is pleased to announce a new clinical research study for qualified study participants pursuing IVF/ICSI. Our clinical research team is dedicated to further pursuing advancements in fertility technology in order to provide our patients with the most recent options by participating in clinical trials and research studies. Throughout the years, we have conducted ground-breaking research that has contributed to improvements in assisted reproductive technologies (ART) and fertility treatment. As a result, our team of revered experts regularly contributes to many leading peer-reviewed fertility journals.
Fertility Centers of Illinois has been offered an exciting opportunity to conduct a new research study sponsored by Ferring Pharmaceuticals. The name of the study is the Comparison of Menopur Liquid and Powder in Women Undergoing ART (CLARA). This study will be conducted at the Fertility Centers of Illinois – Chicago River North IVF Center only.
This is a randomized, double-blind, double-dummy, parallel-group, multicenter non-inferiority trial. Study subjects will be randomly assigned 1:1 to receive either Menopur liquid or Menopur powder. The assigned medication will be completely unknown until after the nationwide study trial has ended.
Participants will receive one complete IVF/ICSI cycle, including all injectable and vaginal medications used for the IVF/ICSI cycle.
Enrollment dates will be December 2019 – ??
We are specifically looking for women who fit the following criteria:
- Pre-menopausal women 18-42 years of age at screening
- BMI 5-38 kg/m2 (inclusive)
- Regular menstrual cycles of 24-35 days, presumed to be ovulatory.
- Documented history of infertility for at least 12 months (for women 35 and under) or 6 months (for women 36 and older) before randomization (not applicable in case of bilateral tubal occlusion or male factor infertility requiring the use of donor sperm.)
- HSG, HSC, or HUS documenting normal uterus at screening or within 1 year prior to screening.
- Presence of both ovaries without evidence of clinically significant abnormality and normal adnexa.
- FSH between 1-12 IU/L within 3 months prior to randomization (cycle day 2-4)
- AMH greater than 1.0 ng/mL at screening
- Willing to accept eSET
- Negative results of ID labs within 6 months prior to study enrollment.
- Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to screening.
- Total testosterone, prolactin, and thyroid-stimulating hormone within normal limits within 12 months prior to screening.
If you have any recommendations for good candidates for this study, please encourage them to apply by sending an email to FCIResearch@integramed.com and to reference the Menopur pen study. Our research department will reply and review their applications for eligibility.
If you have any questions about this or other studies, conducted by Fertility Centers of Illinois, please feel free to reach out to our Research Department, or any of our physicians at 877.324.4483. Thank you for your attention and consideration.