Role of Low Dose Injectable Progesterone in Triggering Ovulation

The General Authority for Teaching Hospitals and Institutes

Status: Enrolling

Conditions: Progesterone; Low Dose; Triggering Ovulation

Treatments: Drug: Progesterone; Drug: Placebo

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06928844

36264PR1017/12/24

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Progesterone group

Experimental group

Description:

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

Treatment:

Drug: Progesterone

Control group

Placebo Comparator group

Description:

Women will receive placebo as a control group

Treatment:

Drug: Placebo