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Follicular Synchronization in Polycystic Ovarian Syndrome Patients Undergoing Intracytoplasmatic Sperm Injection ( ICSI )

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ClinicalTrials.gov Identifier: NCT04069117
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Taman, Mansoura University Hospital

Brief Summary:

The use of GnRH antagonist protocol nowadays is the slandered protocol of controlled ovarian stimulation in patients with poly cystic ovarian syndrome (PCOS) because it decreases the incidence of OHSS(1, 2). However, this protocol may lead to asynchronous growth of follicles with an early dominant follicle specially in PCOS patients(3). In most of cases this phenomenon will affect the IVF outcomes(2, 4) Aromatase inhibitors (AIs) nowadays is recommended to be used for ovulation induction in patients with PCOS (5, 6).It has fewer side effects, and a shorter half-life than clomiphene citrate(CC), and no effect ON the endometrial receptivity. It is used in treating patients with chronic anovulation, unexplained infertility and poor ovarian reserve(7). It acts through decreasing estrogen levels and allows follicle stimulating hormone (FSH) release from the hypothalamus (8, 9). It could be used alone or with combination with human menopausal gonadotropin (HMG) specially in patients with CC resistant(10-13). It also improves the ovarian response to FSH when they are used in combination and it decreases the risk of OHSS (14).

This study aims to evaluate the effect of uses of letrozole in combination with HMG during ovarian stimulation in patients having PCOS undergoing IVF/ICSI on the follicular growth pattern, synchronized growth of follicles, maturity of oocyte and the quality of embryos.


Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Drug: letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland) Phase 4

Detailed Description:

Participants in this study will be group of subfertile women undergoing IVF/ ICSI trial and having polycystic ovarian syndrome Inclusion criteria

  1. Ages ≥20 and <40 years old
  2. Women having the diagnosis of polycystic ovarian syndrome according to Rotterdam criteria (15)
  3. Women who have at least one of the following indications for IVF or ICSI:

    1. Resistance to slandered ovulation induction and life style modification
    2. Tubal factors: unilateral or bilateral tubal obstruction, unilateral or bilateral salpingectomy or tubal ligation
    3. Male factors: oligoasthenozoospermia or obstructive azoospermia Exclusion criteria

1. Women with unexplained infertility. 2. women with poor ovarian reserve according to Bologna criteria (16). 3. Couples with known chromosomal abnormalities. 4. Women who refuse to participate in this study.

Methods

  • patients will be randomly assigned into two groups (100 patients in each group): letrozole group (study group) and non letrozole group (control group). Treatment assignment will be blinded to patients, physicians, and nursing staff.
  • All patients will receive combined oral pills before stimulation.
  • letrozole 2.5mg twice daily (Femara; Novartis Pharma Services, Basel, Switzerland) will be given for 5 days starting from the second day of menstruation in combination with low dose step up stimulation with recombinant FSH in the study group.
  • Allocated patients will be randomized into either of two groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blinded clinical trial
Primary Purpose: Treatment
Official Title: Follicular Synchronization in Polycystic Ovarian Syndrome Patients Undergoing Intracytoplasmatic Sperm Injection With Letrozole /Antagonist Protocol: A Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Active Comparator: • Study group
It contains 100 patients will undergo ovarian stimulation with letrozole 2.5mg twice daily (Femara; Novartis Pharma Services, Basel, Switzerland) for 5 days starting from the first day of menstruation in combination with low dose step up stimulation with recombinant FSH starting in the third day of menstruation.
Drug: letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland)
letrozole /antagonist protocol
Other Name: letroz 2.5mg (Sun Pharmaceuticals Industries Ltd.,India)

No Intervention: • Control group
It contains 100 patients will undergo ovarian stimulation with low dose step up stimulation with recombinant FSH starting in the third day of menstruation



Primary Outcome Measures :
  1. the number of asynchronized follicles in both groups [ Time Frame: 30 min ]
    • Asynchronization will considered when there is a difference of at least 2 mm between the dominant follicle and other follicles



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   subfertile women undergoing IVF/ ICSI trial and having polycystic ovarian syndrome
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Ages ≥20 and <40 years old 2. Women having the diagnosis of polycystic ovarian syndrome according to Rotterdam criteria (15) 3. Women who have at least one of the following indications for IVF or ICSI:

    1. Resistance to slandered ovulation induction and life style modification
    2. Tubal factors: unilateral or bilateral tubal obstruction, unilateral or bilateral salpingectomy or tubal ligation
    3. Male factors: oligoasthenozoospermia or obstructive azoospermia

Exclusion Criteria:

  • 1. Women with unexplained infertility. 2. women with poor ovarian reserve according to Bologna criteria (16). 3. Couples with known chromosomal abnormalities. 4. Women who refuse to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069117


Contacts
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Contact: Mohamed E Taman, MD +2001063516395 dr_mohammed_elsayed@mans.edu.eg
Contact: Mohamed E Taman, MD +2001063516395 dr_mohammed-elsayed@hotmail.com

Locations
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Egypt
Faculty of Medicine Recruiting
Mansoura, Dakahlia, Egypt, 050
Contact: Mohamed E. Taman, MD    +201063516395    dr_mohammed_elsayed@mans.edu.eg   
Sponsors and Collaborators
Mansoura University Hospital
Investigators
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Principal Investigator: Mohamed E Taman, MD Faculty of Medicine - Mansoura University
Publications:

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Responsible Party: Mohamed Taman, lecturer, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04069117    
Other Study ID Numbers: R.19.07.557
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs