Follicular Synchronization in PCOS Patients Undergoing ICSI

NCT04069117 | Completed Phase 4 FDA Drug

• 1 other identifier: R.19.07.557
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

• the number of asynchronized follicles in both groups

  • Asynchronization will considered when there is a difference of at least 2 mm between the dominant follicle and other follicles

  30 min

Study Arms (2)

• Study group

ACTIVE COMPARATOR

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)

• Control group

NO INTERVENTION

It contains 100 patients will undergo ovarian stimulation with low dose step up stimulation with recombinant FSH starting in the third day of menstruation

Interventions

letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland) DRUG

letrozole /antagonist protocol

Also known as: letroz 2.5mg (Sun Pharmaceuticals Industries Ltd.,India)

• Study group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: subfertile women undergoing IVF/ ICSI trial and having polycystic ovarian syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

Related Publications (7)

• Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4.

  PMID: 27126581 BACKGROUND

• Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.

  PMID: 30052961 BACKGROUND

• Wang R, Mol BW. The Rotterdam criteria for polycystic ovary syndrome: evidence-based criteria? Hum Reprod. 2017 Feb;32(2):261-264. doi: 10.1093/humrep/dew287. Epub 2016 Nov 9.

  PMID: 28119448 BACKGROUND

• Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.

  PMID: 25008235 BACKGROUND

• Franik S, Eltrop SM, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for subfertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2018 May 24;5(5):CD010287. doi: 10.1002/14651858.CD010287.pub3.

  PMID: 29797697 BACKGROUND

• Zhao Y, Ruan X, Mueck AO. Letrozole combined with low dose highly purified HMG for ovulation induction in clomiphene citrate-resistant infertile Chinese women with polycystic ovary syndrome: a prospective study. Gynecol Endocrinol. 2017 Jun;33(6):462-466. doi: 10.1080/09513590.2017.1292241. Epub 2017 Feb 28.

  PMID: 28277124 BACKGROUND

• Wang R, Kim BV, van Wely M, Johnson NP, Costello MF, Zhang H, Ng EH, Legro RS, Bhattacharya S, Norman RJ, Mol BW. Treatment strategies for women with WHO group II anovulation: systematic review and network meta-analysis. BMJ. 2017 Jan 31;356:j138. doi: 10.1136/bmj.j138.

  PMID: 28143834 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed E Taman, MD

  Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)