Health Condition 1: Z318- Encounter for other procreative management
Conditions
Interventions
Intervention1: Dydrogest: Dydrogesterone 10 mg TID
Intervention2: Duphaston: Dydrogesterone 10 mg TID
Intervention3: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
Zydus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Female participants aged 18 to 45 years at the time of screening Participants undergoing a programmed frozen embryo transfer FET cycle Participants receiving estradiol hemihydrate 2mg TID for endometrial preparation as part of the programmed FET protocol Confirmed anovulation defined as Absence of a follicle less than or equal to 14 mm on transvaginal ultrasound and Serum progesterone level less than 1 ng mL on Day 13 15 of estradiol administration Planned single Day 5 embryo transfer Ability and willingness to provide written informed consent prior to participation in the study
Exclusion criteria
Exclusion criteria: Escape ovulation defined as serum progesterone more than 1.0 ng mL Presence of uterine malformations or significant endometrial abnormalities that may affect implantation Known contraindications to progestogen therapy Presence of clinically significant hepatic impairment or liver disease Use of any progesterone or progestogen preparation for luteal phase support other than the assigned study medication during the study period Any medical condition or circumstance that, in the opinion of the investigator may interfere with study participation or evaluation of study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Embryo transfer ET day plasma concentrations of dydrogesterone DYD and 20 alpha dihydrodihydrogesterone DHDTimepoint: Baseline Day 2 Day 6 Day 9 Day 13 Day 15 Day 14 Day 30 Day 36 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the clinical pregnancy rates biochemical pregnancy rates live birth rates and miscarriage rates between the two treatment arms from embryo transfer through the completion of pregnancy and delivery To compare neonatal outcomes including congenital anomalies and APGAR scores at birth between the two treatment arms To compare the proportion of participants with low systemic drug exposure defined as DYD less than 0.7 ng mL and DHD less than 20 ng mL) between the two treatment arms on the day of embryo transfer To compare gestational age at outcome defined as the exact gestational age in weeks and days at the time of delivery or pregnancy loss between the two treatment arms To compare additional neonatal outcomes including birth weight grams neonatal intensive care unit NICU admission Yes or No with reason and still birth Yes or No between the two treatment armsTimepoint: Baseline Day 2 Day 6 Day 9 Day 13 Day 15 Day 14 Day 30 Day 36 Day 90 | — |
Countries
India
Contacts
Public ContactDr Sameer Muchhala
Southend Fertility and IVF
Outcome results
None listed