Study on infertility with drug used on IVF patients.
- Conditions
- Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
- Registration Number
- CTRI/2024/04/064994
- Lead Sponsor
- MANKIND PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
? Female patients of age = 21 years.
? Patients who are legally married
? Patients who require Luteal Phase Support during the Assisted reproductive techniques (ART)
? Patients who are prescribed Dydrogesterone as part of routine clinical practice as determined by the Investigator.
? Patients or their legally representatives who are willing provide written informed consent to participate in the study and are willing to adhere to the study procedures as per the protocol.
? Patients with known severe liver or severe kidney or liver
dysfunction at the time of initiation of trial
? Patients who are allergic to Dydrogesterone
? Participation in another study concurrently or within 4 weeks
before initiation of trial.
? Presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may
affect the study outcome parameter data.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with presence of Foetal Heartbeat at approximately 7 weeks of pregnancy. <br/ ><br>Proportion of patients with presence of Foetal Heartbeat at 12 weeks of pregnancy. <br/ ><br>Physician’s global assessment of safety and tolerability of the treatment with Dydrogesterone using a 5-point Likert Scale. <br/ ><br>Patient’s global assessment of acceptability, satisfaction, and tolerability of the treatment with Dydrogesterone using a 5-point Likert Scale.Timepoint: Baseline follow-up after +12 ±5 days, 30 ±10 days, & at 70 ±10 days post embryo transfer,
- Secondary Outcome Measures
Name Time Method Assessment of Per vaginal Bleeding <br/ ><br>Adverse events and serious adverse events reported by patient or identified by the investigator will be recorded and reported. <br/ ><br>Proportion of patients with positive pregnancy testTimepoint: 12 days, 30 days, & at 70 days