Role of Low Dose Injectable Progesterone in Triggering Ovulation

NCT ID: NCT06928844

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-08-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Progesterone group

Women will receive low dose progesterone 5 mg intramuscularly as a study group.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

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).

Control group

Women will receive placebo as a control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 20 to 35 years.
• Infertile women.
• Basal follicle-stimulating hormone (FSH) level <10 mIU/ml.

Exclusion Criteria

• Poor ovarian reserve.
• Immunological disease.
• Endometriosis.
• Uterine abnormality.
• Body mass index (BMI) >30 kg/m2.
• Endometrial thickness <8 or >12 mm on the day of triggering.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The General Authority for Teaching Hospitals and Institutes

NETWORK

Sponsor Role: lead

Responsible Party

Abeer Ali Elshabacy

Assistant Scientific Consultant Obstetrics and Gynecology Benha Teaching Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Teaching Hospitals and Institutes

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Abeer A El Shabasi, MD

Role: CONTACT

abear.elshabacy@gmail.com

00201223331182

Facility Contacts

Abeer A El Shabasi, MD

Role: primary

abear.elshabacy@gmail.com

00201223331182

Other Identifiers

36264PR1017/12/24

Identifier Type: -

Identifier Source: org_study_id