Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
Conditions
Interventions
Sponsors
MANKIND PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with presence of Foetal Heartbeat at approximately 7 weeks of pregnancy. Proportion of patients with presence of Foetal Heartbeat at 12 weeks of pregnancy. Physician’s global assessment of safety and tolerability of the treatment with Dydrogesterone using a 5-point Likert Scale. 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
| Measure | Time frame |
|---|---|
| Assessment of Per vaginal Bleeding Adverse events and serious adverse events reported by patient or identified by the investigator will be recorded and reported. Proportion of patients with positive pregnancy testTimepoint: 12 days, 30 days, & at 70 days | — |
Countries
India
Contacts
Public ContactDr Ashutosh Gautam
Lilavati Hospital
Outcome results
None listed