A Study to Evaluate the Effect of SUREMA XT Combined with Letrozole on AMH Levels and Ovulation in Women with Poor Ovarian Response

A clinical study to evaluate the efficacy and safety of SUREMA XT as an add on therapy to Letrozole to improve AMH levels and ovulation rate in Poor Ovarian Response in female infertility. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086691

Enrollment

Registered

2025-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N970- Female infertility associated withanovulation

Interventions

Intervention1: SUREMA XT (Taken once daily orally) + Letrozole (menstrual cycle days 2 to 6): Ubiquinol Acetate 100 mg, L-Ornithine 50 mg, Melatonin 3 mg, L-Methyl Folate 570 mcg, Vitamin D2 600 IU,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female subjects with age range of 21 40 years 2. BMI less than 35 kg/m2 3. Female with diminished ovarian reserve (DOR) 4. Female with premature ovarian insufficiency (POI) 5. Infertility due to anovulation 6. No recent (within 6 months) treatment for induction of ovulation 7. Participants should have not participated in any other clinical trial during the past 3 months. 8. Those participants, with their spouse s consent are willing to a part of the study.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled Diabetes (HBa1C less 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 activity 5. Suffering which can interfere with present study as decided by clinical investigator 6. History of hypersensitivity to any of the test products. 7. 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, AFC and AMH. [ time frame over 3 cycles- at baseline and post study] 3. Changes from base line to 3rd cycle in Quality of life- Questionnaires (Short Form Health-12). [pre and post study]Timepoint: Visit 1 (day 0), Visit 2 (cycle 1), visit 3 (cycle 2), visit 3 (cycle 3)	—

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, AFC and AMH. [ time frame over 3 cycles- at baseline and post study] 3. Changes from base line to 3rd cycle in Quality of life- Questionnaires (Short Form Health-12). [pre and post study]Timepoint: Visit 1 (day 0), Visit 2 (cycle 1), visit 3 (cycle 2), visit 3 (cycle 3)

—

Secondary

Measure	Time frame
1. Pregnancy rate 2. To demonstrate safety and tolerability of study product by clinical AEs 3. Adverse events and serious adverse events during the study periodTimepoint: Visit 1 (day 0), Visit 2 (cycle 1), visit 3 (cycle 2), visit 3 (cycle 3)	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

KI3 PRIVATE LIMITED

saheerose@gmail.com9843591097

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026