Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients
Brief Summary: This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.


Options:
A: Arm Label: Menotropin/Progesterone vaginal insert; Type: EXPERIMENTAL; Interventions: Drug: Menotropin, Drug: Progesterone vaginal insert, Drug: leuprolide acetate | Arm Label: Menotropin/Progesterone in oil; Type: EXPERIMENTAL; Interventions: Drug: Menotropin, Drug: Progesterone in oil, Drug: leuprolide acetate | Arm Label: Follitropin beta/Progesterone vaginal insert; Type: ACTIVE_COMPARATOR; Interventions: Drug: Progesterone vaginal insert, Drug: Follitropin beta, Drug: leuprolide acetate | Arm Label: Follitropin beta/Progesterone in oil; Type: ACTIVE_COMPARATOR; Interventions: Drug: Follitropin beta, Drug: Progesterone in oil, Drug: leuprolide acetate | Intervention Type: DRUG; Name: Menotropin; Assigned to Arm(s): Menotropin/Progesterone in oil, Menotropin/Progesterone vaginal insert | Intervention Type: DRUG; Name: Progesterone vaginal insert; Assigned to Arm(s): Follitropin beta/Progesterone vaginal insert, Menotropin/Progesterone vaginal insert | Intervention Type: DRUG; Name: Follitropin beta; Assigned to Arm(s): Follitropin beta/Progesterone in oil, Follitropin beta/Progesterone vaginal insert | Intervention Type: DRUG; Name: Progesterone in oil; Assigned to Arm(s): Follitropin beta/Progesterone in oil, Menotropin/Progesterone in oil | Intervention Type: DRUG; Name: leuprolide acetate; Assigned to Arm(s): Follitropin beta/Progesterone in oil, Follitropin beta/Progesterone vaginal insert, Menotropin/Progesterone in oil, Menotropin/Progesterone vaginal insert
B: Arm Label: Young postmenopausal women; Type: EXPERIMENTAL; Interventions: Drug: GnRH, Drug: NAL-GLU GnRH antagonist, Drug: Estrogen patch | Arm Label: Older postmenopausal women; Type: EXPERIMENTAL; Interventions: Drug: GnRH, Drug: NAL-GLU GnRH antagonist, Drug: Estrogen patch | Intervention Type: DRUG; Name: GnRH; Assigned to Arm(s): Older postmenopausal women, Young postmenopausal women | Intervention Type: DRUG; Name: NAL-GLU GnRH antagonist; Assigned to Arm(s): Older postmenopausal women, Young postmenopausal women | Intervention Type: DRUG; Name: Estrogen patch; Assigned to Arm(s): Older postmenopausal women, Young postmenopausal women
C: Arm Label: Aromatase Inhibitors (AI); Type: ACTIVE_COMPARATOR; Interventions: Drug: Letrozole (aromatase inhibitor) | Arm Label: Clomiphene Citrate (CC); Type: ACTIVE_COMPARATOR; Interventions: Drug: Clomiphene Citrate | Arm Label: Follicle Stimulating Hormone (FSH); Type: ACTIVE_COMPARATOR; Interventions: Drug: Follicle Stimulating Hormone (gonadotropin) | Intervention Type: DRUG; Name: Letrozole (aromatase inhibitor); Assigned to Arm(s): Aromatase Inhibitors (AI) | Intervention Type: DRUG; Name: Clomiphene Citrate; Assigned to Arm(s): Clomiphene Citrate (CC) | Intervention Type: DRUG; Name: Follicle Stimulating Hormone (gonadotropin); Assigned to Arm(s): Follicle Stimulating Hormone (FSH)
D: Arm Label: Endometrial biopsy arm; Type: EXPERIMENTAL; Interventions: Procedure: Endometrial biopsy, Device: Transvaginal ultrasound | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Endometrial biopsy; Assigned to Arm(s): Endometrial biopsy arm | Intervention Type: DEVICE; Name: Transvaginal ultrasound; Assigned to Arm(s): Endometrial biopsy arm

Answer: A