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The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone group | Experimental | Women will receive low dose progesterone 5 mg intramuscularly as a study group. |
|
| Control group | Placebo Comparator | Women will receive placebo as a control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ovulation rates | Incidence of ovulation rates will be recorded. | 10-12 days of the menstrual cycle |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Infertile women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abeer A El Shabasi, MD | Contact | 00201223331182 | abear.elshabacy@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospitals and Institutes | Recruiting | Cairo | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 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). |
|
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 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |