Random Start Ovarian Stimulation Protocol Vs Conventional Early Follicular Phase Ovarian Stimulation in ART, A Multicenter Randomized Trial.

This prospective, open-label, multicentre, randomized,parallel-group study will be conducted in women aged 25 to 37 years (bothinclusive), who are indicated to undergo COS as part of ART. Each woman willparticipate in the study for a maximum duration of approximately 28 weeks aftersigning the informed consent form (ICF). This will include a screening period,a single cycle of COS and ART procedures, and post-ART follow-up for ongoingpregnancy till 12 completed weeks of gestation.

The screening tests will be done as per the Scheduleof Assessments (SOA). The screening phase is planned for a maximum duration of2 menstrual cycles, to allow time-specific assessments of the femalereproductive hormones, exclusion of pregnancy, confirmation of ovarian reserve,and other suitable assessments to evaluate the subject’s eligibility.Eligibility of the subject will be determined based on the results of all thetests performed during the screening period, (reports of which should beavailable with the investigator prior to initiation of COS.)

Once the participant is eligible to undergocontrolled ovarian stimulation, she will be randomized to either of 3 ARMS (ARM1- Start of stimulation on Day 2/Day 3 Cycle, ARM 2- Late Follicular Phase (Startof stimulation on Day 12- Day 14 of the menstrual cycle), ARM 3- Start ofstimulation on Luteal Phase (Day 20 – Day 24 of the menstrual cycle).