Role of Low Dose Injectable Progesterone in Triggering Ovulation

Not Applicable

Recruiting

• Conditions: Low Dose; Progesterone; Triggering Ovulation
• Interventions: Drug: Progesterone; Drug: Placebo

• Registration Number: NCT06928844
• Lead Sponsor: The General Authority for Teaching Hospitals and Institutes

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.

Study Timeline

• Study First Submitted: 2025-02-12
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Study Start: 2025-04-15
• Study First Posted: 2025-04-15
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone group	Progesterone	Women will receive low dose progesterone 5 mg intramuscularly as a study group.
Control group	Placebo	Women will receive placebo as a control group

Primary Outcome Measures

Name	Time	Method
Incidence of ovulation rates	10-12 days of the menstrual cycle	Incidence of ovulation rates will be recorded.

Secondary Outcome Measures

Name	Time	Method
Follicle stimulating hormone (FSH)levels	10-12 days of the menstrual cycle	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.
Luteinizing hormone (LH)levels	10-12 days of the menstrual cycle	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).
Mature oocytes	16 days of the menstrual cycle	Mature oocytes will be recorded.
Estradiol (E2) levels	10-12 days of the menstrual cycle	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.
Progesterone levels	10-12 days of the menstrual cycle	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.
Number of oocytes	8 days of the menstrual cycle	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.
Clinical pregnancy rate.	One week late from the previous menstrual cycle	Clinical pregnancy rate will be recorded.
Biochemical pregnancy	16 days of the menstrual cycle	Biochemical pregnancy will be recorded through a blood pregnancy test on the date of the next menstrual period
Early miscarriage rate	16 days of the menstrual cycle	Early miscarriage rate will be recorded.

Trial Locations

Locations (1)

Teaching Hospitals and Institutes; 🇪🇬 Cairo, Egypt