NCT06928844

Role of Low Dose Injectable Progesterone in Triggering Ovulation

Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The General Authority for Teaching Hospitals and Institutes · Network
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.

Detailed description

Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility. Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis. Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.

Conditions

• Low Dose
• Progesterone
• Triggering Ovulation

Interventions

Type	Name	Description
DRUG	Progesterone	Women will receive low dose progesterone 5 mg intramuscularly as a study group. (Letrozole 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).
DRUG	Placebo	Women will receive placebo as a control group. (Placebo 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-04-15
• Last updated: 2025-04-16

Locations

1 site across 1 country: Egypt