Role of Low Dose Injectable Progesterone in Triggering Ovulation

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

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

Study Overview

• Status: Recruiting
• Conditions: Progesterone; Low Dose; Triggering Ovulation
• Intervention / Treatment: Drug: Progesterone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abeer A El Shabasi, MD; Phone Number: 00201223331182; Email: abear.elshabacy@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Teaching Hospitals and Institutes
    • Contact: Abeer A El Shabasi, MD; Phone Number: 00201223331182; Email: abear.elshabacy@gmail.com
    • Principal Investigator: Mohamed A Raslan, MD
    • Principal Investigator: Mona A Baghdadi, MD
    • Principal Investigator: Sayida I El-Dessouki, MD
    • Principal Investigator: Eslam M El-Sayed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progesterone group; Women will receive low dose progesterone 5 mg intramuscularly as a study group.	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).
Placebo Comparator: Control group; Women will receive placebo as a control group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ovulation rates	Incidence of ovulation rates will be recorded.	10-12 days of the menstrual cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicle stimulating hormone (FSH)levels	Follicle stimulating hormone (FSH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.	10-12 days of the menstrual cycle
Luteinizing hormone (LH)levels	Luteinizing hormone (LH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval).	10-12 days of the menstrual cycle
Estradiol (E2) levels	Estradiol (E2) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.	10-12 days of the menstrual cycle
Progesterone levels	Progesterone levels will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.	10-12 days of the menstrual cycle
Number of oocytes	Number of oocytes will be recorded. Ovulation monitoring will be done from the last day of the cycle until ovulation occurs approximately in the middle of the cycle.	8 days of the menstrual cycle
Mature oocytes	Mature oocytes will be recorded.	16 days of the menstrual cycle
Clinical pregnancy rate.	Clinical pregnancy rate will be recorded.	One week late from the previous menstrual cycle
Biochemical pregnancy	Biochemical pregnancy will be recorded through a blood pregnancy test on the date of the next menstrual period	16 days of the menstrual cycle
Early miscarriage rate	Early miscarriage rate will be recorded.	16 days of the menstrual cycle

Collaborators and Investigators

• Sponsor: The General Authority for Teaching Hospitals and Institutes

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 36264PR1017/12/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No