Study of extended Letrozole treatment protocol (7 and 10 days) on the ovulation induction and clinical pregnancy in conventional treatment-resistant (5 days) Poly Cystic Ovary Syndrome patients
- Conditions
- Infertility.Female infertility
- Registration Number
- IRCT20110908007513N19
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 66
BMI less than 35
PCOS diagnosis based on Rotterdam criteria
Male sexual health(A sperm concentration of 14 million per milliliter, with the presence of motile sperm observed in at least one ejaculation within the past year.)
willingness to engage in regular sexual intercourse during the period of the study
Consent to participate in the study (this consent includes both partners, as the informed cooperation and participation of the wife is also one of the necessities of the study
No response to the treatment with 5 milligrams of Letrozole for 5 days
Patients who have uncontrolled thyroid disease or hyperprolactinemia, or a testosterone level exceeding 150 nanograms per milliliter.
Contraindication for pregnancy
Concurrent administration of other ovulation inducers such as Metformin, Clomiphene Citrate, and Gonadotropins
Unwillingness to enter to the study
Use of drugs that interact with Letrozole
Previous hypersensitivity to the Letrozole
Positive pregnancy test
Use of fertility-affecting drugs in the past three months, including: OCP, GnRH agonists and antagonists, anti-androgens, gonadotropins, antiobesity drugs, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. No past anti-fertility activities such as vasectomy and fallopian tube ligation.
Patients with very high androgen levels are initially screened for Cushing’s syndrome (urinary cortisol level) and adult adrenal hyperplasia (by measuring 17-a-hydroxyl-progesterone). If these conditions are present, they are not included in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Pregnancy rate. Timepoint: 6 weeks following starting intervention. Method of measurement: transvaginal ultrasonography.
- Secondary Outcome Measures
Name Time Method Ovulation Rate. Timepoint: Two days after the end of the medication until the dominant follicle disappears. Method of measurement: Transvaginal Ultrasonography.;Chemical pregnancy rate. Timepoint: Two weeks following ovulation. Method of measurement: Blood Test.;Ovarian hyperstimulation syndrome. Timepoint: From the time of completion of the drug to the end of the study. Method of measurement: Based on clinical signs.;Pregnancy complication(early pregnancy loss, multiple pregnancy rate). Timepoint: From the time of pregnancy until the end of week 12. Method of measurement: Clinical symptoms and transvaginal ultrasonography.;Prominent follicle size. Timepoint: Two to six days following intervention discontinuation. Method of measurement: transvaginal ultrasonography.