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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110908007513N19
Enrollment
66
Registered
2024-07-01
Start date
2024-06-25
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility. Female infertility

Interventions

Intervention 1: In this group, we place patients with PCOS who are resistant to the conventional treatment of daily intake of 5 milligrams of oral Letrozole for 5 days under a new treatment protocol o

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Clinical Pregnancy rate. Timepoint: 6 weeks following starting intervention. Method of measurement: transvaginal ultrasonography.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Zamani Dehkordi

Esfahan University of Medical Sciences

nastaran14zd@gmail.com+98 991 314 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026