Health Condition 1: E283- Primary ovarian failure
Conditions
Interventions
Intervention1: Fertilix Ova: Fertilix Ova (Taken once daily orally) + Letrozole
(Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5-7.5 mg mg in the next cycle if there
Sponsors
Innovcare Life sciences Pvt. Ltd., India.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects with age 21 – 45 years 2. BMI less than 35 3. Infertility due to anovulation. 4. No recent (within 6 months) treatment for induction of ovulation 5. Patient should have not participated in any other clinical trial during the past 3 months. 6. Participants, who are willing to give written, signed and dated informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled Diabetes (HbA1c greater than 10) 2. PCOS 3. Moderate to severe renal or hepatic impairment 4. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity 5. Suffering from any illness which will interfere with present study as decided by clinical investigator 6. History of hypersensitivity to any of the test products. 7. Participants who are pregnant. 8. Any other condition decided as unfit for study by Clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures to study the efficacy are as follows: 1. Ovulation rate – monitored by USG abdomen. 2. Ovarian reserve by monitoring Estrogen and AMH. [ time frame over 12 weeks/ 3 cycles- at baseline and post study] 3. Changes from base line to 12 weeks in Quality of life- Questionnaires (Short Form Health-12 ). [pre and post study] Timepoint: Day 0, Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pregnancy rate 2. To demonstrate safety and tolerability of study product by Clinical AEs (If any) Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study period Timepoint: Day 0 and week 12 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Pvt Ltd
Outcome results
None listed