Role of Low Dose Injectable Progesterone in Triggering Ovulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Progesterone, Placebo.
- Who it may be relevant to
- Registry conditions: Low Dose, Progesterone, Triggering Ovulation. Basic parameters: 20 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial
Overview
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.
Interventions
- 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). - 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).
Primary outcome measures
- Incidence of ovulation rates [Time frame: 10-12 days of the menstrual cycle]
Secondary outcome measures (9)
- Follicle stimulating hormone (FSH)levels [Time frame: 10-12 days of the menstrual cycle]
- Luteinizing hormone (LH)levels [Time frame: 10-12 days of the menstrual cycle]
- Estradiol (E2) levels [Time frame: 10-12 days of the menstrual cycle]
- Progesterone levels [Time frame: 10-12 days of the menstrual cycle]
- Number of oocytes [Time frame: 8 days of the menstrual cycle]
- Mature oocytes [Time frame: 16 days of the menstrual cycle]
- Clinical pregnancy rate. [Time frame: One week late from the previous menstrual cycle]
- Biochemical pregnancy [Time frame: 16 days of the menstrual cycle]
- Early miscarriage rate [Time frame: 16 days of the menstrual cycle]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Teaching Hospitals and Institutes — Cairo
Identifiers
NCT: NCT06928844 · 36264PR1017/12/24