NCT Number: NCT06928844
The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.
Interested in participating?
Request Info20 year–35 year
Female
Interventional
Not applicable
Cairo, Egypt
Location status: Recruiting
Abeer A El Shabasi, MD
CONTACT
Eslam M El-Sayed, MD
PRINCIPAL_INVESTIGATOR
Mohamed A Raslan, MD
PRINCIPAL_INVESTIGATOR
Mona A Baghdadi, MD
PRINCIPAL_INVESTIGATOR
Sayida I El-Dessouki, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: 10-12 days of the menstrual cycle
Incidence of ovulation rates will be recorded.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 days of the menstrual cycle
Mature oocytes will be recorded.
Time frame: One week late from the previous menstrual cycle
Clinical pregnancy rate will be recorded.
Time frame: 16 days of the menstrual cycle
Biochemical pregnancy will be recorded through a blood pregnancy test on the date of the next menstrual period
Time frame: 16 days of the menstrual cycle
Early miscarriage rate will be recorded.
Contact information is provided by the study sponsor or research team.
The General Authority for Teaching Hospitals and Institutes
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Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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