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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

Protocol summary

Study aim
Comparing the effectiveness of long-term treatment protocol with Letrozole (7-day and 10-day) in inducing ovulation and clinical pregnancy in patients with Polycystic Ovary Syndrome (PCOS) resistant to the usual Letrozole treatment (5-day).
Design
This study is designed as a parallel randomized clinical trial on 66 patients, with random allocation conducted through an online randomization system.
Settings and conduct
This study will be conducted in Isfahan university fertility clinic on patients resistant to 5-day Letrozole treatment. In this study, patients will undergo treatment with a long-term treatment protocol of either 7 or 10 days
Participants/Inclusion and exclusion criteria
inclusion Criteria • BMI less than or equal to 35 • Diagnosis of PCOS based on Rotterdam criteria • Male sexual health • Willingness to have regular sexual intercourse during the study • Consent to participate in the study • No response to 5 mg Letrozole treatment for 5 days Exclusion Criteria • Patients with uncontrolled thyroid disease, hyperprolactinemia, or testosterone level exceeding 150 nanograms per milliliter • Presence of contraindications to pregnancy • Concurrent use of other ovulation inducers such as Metformin, Clomiphene Citrate, and Gonadotropins • Use of drugs that interact with Letrozole • Allergy to Letrozole • Positive pregnancy test • Previous disease: History of thrombosis, uncontrolled diabetes, liver and kidney failure, history of previous or current breast, endometrial, and cervical carcinomas • Use of fertility-affecting drugs in the past three months • No past anti-fertility activities • Patients with very high androgen levels
Intervention groups
7-day treatment with 5 milligrams of Letrozole daily 10-day treatment with 5 milligrams of Letrozole daily
Main outcome variables
Relative frequency of clinical pregnancy (fetal heartbeat and pregnancy sac in sonography.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110908007513N19
Registration date: 2024-07-01, 1403/04/11
Registration timing: registered_while_recruiting

Last update: 2024-07-01, 1403/04/11
Update count: 0
Registration date
2024-07-01, 1403/04/11
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-25, 1403/04/05
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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:
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-α-hydroxyl-progesterone). If these conditions are present, they are not included in the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation process will be conducted utilizing the random number generation feature provided by the https://www.sealedenvelope.com/ website, employing Variable Size block randomization with a 1:1 allocation ratio across blocks of 4, 6, and 8. The random numbers generated will be segregated into two equal groups denoted as Group A (representing 7 days treatment) and Group B (representing 10 days treatment), each assigned a specific code generated by the aforementioned website. Subsequently, each enrolled patient will be allocated to either the 7 days or 10 days treatment group based on the generated random list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is designed as a parallel randomized clinical trial with the aim of comparing two long-term treatment protocols (7-day and 10-day) with Letrozole in the treatment of PCOS patients resistant to 5-day Letrozole treatment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committees of medical school of Isfahan University of Medical Sciences
Street address
Hezar jarib Ave, Medical school building of Isfahan medical university
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.ARI.MUI.REC.1403.051

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Clinical Pregnancy rate
Timepoint
6 weeks following starting intervention
Method of measurement
transvaginal ultrasonography

Secondary outcomes

1

Description
Ovulation Rate
Timepoint
Two days after the end of the medication until the dominant follicle disappears
Method of measurement
Transvaginal Ultrasonography

2

Description
chemical pregnancy rate
Timepoint
Two weeks following ovulation
Method of measurement
Blood Test

3

Description
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

4

Description
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

5

Description
prominent follicle size
Timepoint
Two to six days following intervention discontinuation
Method of measurement
transvaginal ultrasonography

Intervention groups

1

Description
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 of daily intake of 5 milligrams of Letrozole for 7 days
Category
Treatment - Drugs

2

Description
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 of daily intake of 5 milligrams of Letrozole for 10 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center
Full name of responsible person
Ferdous Mehrabian Mohammadi
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 113 4081
Email
mehrabian@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ferdous Mehrabian Mohammadi
Street address
School of Medicine - Isfahan University of Medical Sciences - Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 113 4081
Email
mehrabian@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nastaran Zamani Dehkordi
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 991 314 4001
Email
nastaran14zd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Physician
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 113 4081
Fax
+98 31 1236 4210
Email
tehrani@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nastaran Zamani Dehkordi
Position
Physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 991 314 4001
Email
nastaran14zd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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