Role of Low Dose Injectable Progesterone in Triggering Ovulation

NCT06928844 | Recruiting

• 1 other identifier: 36264PR1017/12/24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Dose; Progesterone; Triggering Ovulation

Outcome Measures

Primary Outcomes (1)

• Incidence of ovulation rates

  Incidence of ovulation rates will be recorded.

  10-12 days of the menstrual cycle

Secondary Outcomes (9)

• Follicle stimulating hormone (FSH)levels

  10-12 days of the menstrual cycle

• Luteinizing hormone (LH)levels

  10-12 days of the menstrual cycle

• Estradiol (E2) levels

  10-12 days of the menstrual cycle

• Progesterone levels

  10-12 days of the menstrual cycle

• Number of oocytes

  8 days of the menstrual cycle

Study Arms (2)

Progesterone group

EXPERIMENTAL

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

Drug: Progesterone

Control group

PLACEBO COMPARATOR

Women will receive placebo as a control group

Drug: Placebo

Interventions

Progesterone 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).

Progesterone group

Placebo 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).

Control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Infertile women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The General Authority for Teaching Hospitals and Institutes: lead

Study Sites (1)

Teaching Hospitals and Institutes

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Abeer A El Shabasi, MD

CONTACT

00201223331182; abear.elshabacy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientific Consultant Obstetrics and Gynecology Benha Teaching Hospital

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: April 15, 2025
• Study Start: April 15, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)