Low Dose, Progesterone, Triggering Ovulation
Conditions
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.
Interventions
DRUGProgesterone
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).
DRUGPlacebo
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).
Sponsors
The General Authority for Teaching Hospitals and Institutes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ovulation rates | 10-12 days of the menstrual cycle | Incidence of ovulation rates will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| Mature oocytes | 16 days of the menstrual cycle | Mature oocytes will be recorded. |
Countries
Egypt
Contacts
Primary ContactAbeer A El Shabasi, MD
Outcome results
None listed