This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.
The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction (OI). This decision was not related to any safety or efficacy concerns over the use of AS900672-Enriched in OI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
71
Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Merck Serono S.A.
Geneva, Switzerland
Percentage of Participants With Ovulation
Ovulation was defined as a mid-luteal phase progesterone (P4) level \>= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter \[ng/mL\]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.
Time frame: Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])
Percentage of Participants With Clinical Pregnancy
Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Time frame: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])
Duration of Ovarian Stimulation
Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).
Time frame: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Duration of Supplemental Follitropin Alfa Treatment
Time frame: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Cumulative Dose of Supplemental Follitropin Alfa Administered
Time frame: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])
Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm
Time frame: Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.
Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to \[=\<\] 3 follicles with a mean diameter of greater than or equal to \[\>=\] 14 millimeter \[mm\], and one or two of these follicles with a diameter of \>= 17 mm).