The Letrozole Administration During Luteal Phase

NCT02686151 | Unknown Phase 3

• 1 other identifier: Bhsu
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of letrozole in patients who have high risk of ovarian hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were calculated between letrozole group and supporting treatment group.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

Letrozole; OHSS

Outcome Measures

Primary Outcomes (1)

• The incidence of early OHSS

  one year

Study Arms (2)

letrozole

ACTIVE COMPARATOR

2.5mg/tablet(Jiangsu Hengrui Medicine Co., Ltd. products), orally taken 5mg once a day for 5 days

Drug: Letrozole

Polygeline Injection

OTHER

500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days

Drug: Polygeline; Drug: Sodium Chloride; Drug: dexamethasone

Interventions

Letrozole DRUG

used after oocyte retrieval

Also known as: Femara

letrozole

Polygeline DRUG

used after oocyte retrieval

Also known as: polyegline

Polygeline Injection

Sodium Chloride DRUG

used after oocyte retrieval

Also known as: Natrum muriaticum

Polygeline Injection

dexamethasone DRUG

used after oocyte retrieval

Also known as: dexametona

Polygeline Injection

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• oocyte is more than or equal to 20;
• hCG injection on serum estradiol levels greater than or equal to 5000 pmol/L; 3. on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm;
• \. follicle puncture is larger than or equal to number 20.

You may not qualify if:

• Allergic to the letrozole or polygeline.

Sponsors & Collaborators

• The Affiliated Hospital of Inner Mongolia Medical University: lead

Study Sites (1)

The Affiliated Hospital of Inner Mongolia Medical University

Inner Mongolia, China

Location

Related Publications (11)

• He Q, Xu J, Cui S, Li H, Zhang C. [Relationship between letrozole administration during the luteal phase after oocyte retrieval and the early-stage ovarian hyperstimulation syndrome oocurrence]. Zhonghua Fu Chan Ke Za Zhi. 2014 Dec;49(12):909-13. Chinese.

  PMID: 25608991 BACKGROUND

• Wang YQ, Yang J, Xu WM, Xie QZ, Yan WJ, Yin TL, Cheng D, Xiao ZN, Li J. [Luteal letrozole administration decreases serum estrogen level but not the risk of ovarian hyperstimulation syndrome]. Beijing Da Xue Xue Bao Yi Xue Ban. 2013 Dec 18;45(6):869-72. Chinese.

  PMID: 24343064 BACKGROUND

• Wiwanitkit V. Letrozole and gonadotropins versus luteal estradiol and GnRH-antagonist protocol: additional concerns. Fertil Steril. 2011 Jun 30;95(8):e78; author reply e80. doi: 10.1016/j.fertnstert.2011.05.009. Epub 2011 May 24. No abstract available.

  PMID: 21605857 BACKGROUND

• Elassar A, Engmann L, Nulsen J, Benadiva C. Letrozole and gonadotropins versus luteal estradiol and gonadotropin-releasing hormone antagonist protocol in women with a prior low response to ovarian stimulation. Fertil Steril. 2011 Jun;95(7):2330-4. doi: 10.1016/j.fertnstert.2011.03.103. Epub 2011 Apr 22.

  PMID: 21514582 BACKGROUND

• Montville CP, Khabbaz M, Aubuchon M, Williams DB, Thomas MA. Luteal support with intravaginal progesterone increases clinical pregnancy rates in women with polycystic ovary syndrome using letrozole for ovulation induction. Fertil Steril. 2010 Jul;94(2):678-83. doi: 10.1016/j.fertnstert.2009.03.088. Epub 2009 Jun 9.

  PMID: 19515366 BACKGROUND

• Fatemi HM, Popovic-Todorovic B, Donoso P, Papanikolaou E, Smitz J, Devroey P. Luteal phase oestradiol suppression by letrozole: a pilot study in oocyte donors. Reprod Biomed Online. 2008 Sep;17(3):307-11. doi: 10.1016/s1472-6483(10)60212-x.

  PMID: 18764999 BACKGROUND

• Garcia-Velasco JA, Quea G, Piro M, Mayoral M, Ruiz M, Toribio M, Requena A. Letrozole administration during the luteal phase after ovarian stimulation impacts corpus luteum function: a randomized, placebo-controlled trial. Fertil Steril. 2009 Jul;92(1):222-5. doi: 10.1016/j.fertnstert.2008.04.042. Epub 2008 Aug 16.

  PMID: 18710719 BACKGROUND

• Sh Tehrani Nejad E, Abediasl Z, Rashidi BH, Azimi Nekoo E, Shariat M, Amirchaghmaghi E. Comparison of the efficacy of the aromatase inhibitor letrozole and clomiphen citrate gonadotropins in controlled ovarian hyperstimulation: a prospective, simply randomized, clinical trial. J Assist Reprod Genet. 2008 May;25(5):187-90. doi: 10.1007/s10815-008-9209-2. Epub 2008 Apr 19.

  PMID: 18427974 BACKGROUND

• Ortiz ME, Ortiz RE, Garfield R, Zepeda AJ, Croxatto HB. Progesterone, but not luteal estrogen, is required for the establishment of pregnancy in the new world monkey Cebus apella. Am J Primatol. 2007 Oct;69(10):1131-40. doi: 10.1002/ajp.20408.

  PMID: 17387700 BACKGROUND

• Barroso G, Menocal G, Felix H, Rojas-Ruiz JC, Arslan M, Oehninger S. Comparison of the efficacy of the aromatase inhibitor letrozole and clomiphene citrate as adjuvants to recombinant follicle-stimulating hormone in controlled ovarian hyperstimulation: a prospective, randomized, blinded clinical trial. Fertil Steril. 2006 Nov;86(5):1428-31. doi: 10.1016/j.fertnstert.2006.03.044. Epub 2006 Sep 14.

  PMID: 16978619 BACKGROUND

• Fatemi HM, Kolibianakis E, Tournaye H, Camus M, Van Steirteghem AC, Devroey P. Clomiphene citrate versus letrozole for ovarian stimulation: a pilot study. Reprod Biomed Online. 2003 Nov;7(5):543-6. doi: 10.1016/s1472-6483(10)62070-6.

  PMID: 14680546 BACKGROUND

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Letrozole; Polygeline; Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

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; Polymers; Macromolecular Substances; Peptides; Amino Acids, Peptides, and Proteins; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yu Wang, PhD

  Inner Mongolia Medical University affiliated Hospital

  PRINCIPAL INVESTIGATOR

• Xiujuan Chen, MD

  Inner Mongolia Medical University affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, PhD

CONTACT

+86-18604718958; wuai1544@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: February 19, 2016
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)