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Success rate evaluation of Infertility procedure

Open-label observational study to evaluate the success rate of Intra-Uterine Insemination in Infertile women with suspected Luteal phase deficiency

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/02/004407
Enrollment
60
Registered
2014-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Luteal Phase Deficiency

Interventions

Intervention1: 1. Oral Micronized Natural Progesterone Sustained release or 2. Dydrogesterone: 1. 400 mg- 1 tab at bedtime orally for 4 weeks 2. 10 mg- 1 tab twice daily orally for 4 weeks Intervent

Sponsors

Sooriya Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Married females (18 to 33 yrs) with at least Three years history of Infertility • Suspected or documented evidence of Luteal Phase defect with or without history of Recurrent pregnancy loss, OR • Unexplained infertility

Exclusion criteria

Exclusion criteria: • History of Progesterone (Natural or synthetic) use in the past three months • History of tubal insufficiency or obstruction including Endometriosis or Polycystic Ovarian Syndrome • History of psychoactive disease or on antidepressants • AST and / or ALT more than 2.5 x ULN (active liver disease) • Serum creatinine more than 1.5 mg/dl (active renal disease) • Women with Uncontrolled hypertension, hypercholesterolemia or diabetes • Women with history of smoking, myocardial infarction, stroke, cardiovascular/circulatory or clotting disorders • Women on oral anticoagulants or prolonged use of high doses of NSAIDs • Hypersensitivity to Natural micronized progesterone or Dydrogesterone

Design outcomes

Primary

MeasureTime frame
Percentage patients with successful pregnancy confirmed by Urinary HCGTimepoint: 4 weeks

Secondary

MeasureTime frame
Percentage patients with Sr. Progesterone levels more than 10 ng/mlTimepoint: Day 23 of the cycle

Countries

India

Contacts

Public ContactDr Krishnaprasad

SOORIYA Hospital

dgopinath@yahoo.com

Outcome results

None listed

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