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The Letrozole Administration During Luteal Phase

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Letrozole
Polygeline
Sodium Chloride
dexamethasone
Sponsored by
The Affiliated Hospital of Inner Mongolia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring Letrozole, OHSS

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. oocyte is more than or equal to 20;
  2. 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;

4. follicle puncture is larger than or equal to number 20.

Exclusion criteria:

Allergic to the letrozole or polygeline.

Sites / Locations

  • The Affiliated Hospital of Inner Mongolia Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

letrozole

Polygeline Injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of early OHSS

Secondary Outcome Measures

Full Information

First Posted
August 20, 2015
Last Updated
July 18, 2023
Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02686151
Brief Title
The Letrozole Administration During Luteal Phase
Official Title
The Randomized Clinical Trials of Letrozole Administration During Luteal Phase in Patients Who Have the Risk of Ovarian Hyperstimulation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Inner Mongolia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Object: Infertility patients who frozen all embryos due to the risk of OHSS were randomized allocated to letrozole or polygeline injection group. Inclusion criteria meet one of the following conditions: (1) oocyte is more than or equal to 20; (2) human chorionic gonadotropin (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 (4) follicle puncture is larger than or equal to number 20. After the informed consent was signed, letrozole or polygeline injection was randomized allocated after oocyte retrieval. OHSS was determined according to Golan diagnosis standards. Clinical data: Including age, infertility duration, body mass index (BMI), basic follicle-stimulating hormone (FSH) and luteinizing hormone (LH), antral follicle number (AFC), Gn dosage, estradiol level on hCG injection day, the number of oocytes, the number of embryos, early onset OHSS incidence, and the existence of ascites. Reproductive hormone levels: 1, 4, 7, days after taken letrozole, and the supernatant was collected for serum reproductive hormone test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
Letrozole, OHSS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
letrozole
Arm Type
Active Comparator
Arm Description
2.5mg/tablet(Jiangsu Hengrui Medicine Co., Ltd. products), orally taken 5mg once a day for 5 days
Arm Title
Polygeline Injection
Arm Type
Other
Arm Description
500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection,once a day for 2 days
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
used after oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
Polygeline
Other Intervention Name(s)
polyegline
Intervention Description
used after oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Other Intervention Name(s)
Natrum muriaticum
Intervention Description
used after oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
dexametona
Intervention Description
used after oocyte retrieval
Primary Outcome Measure Information:
Title
The incidence of early OHSS
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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; 4. follicle puncture is larger than or equal to number 20. Exclusion criteria: Allergic to the letrozole or polygeline.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, PhD
Phone
+86-18604718958
Email
wuai1544@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Wang, PhD
Organizational Affiliation
Inner Mongolia Medical University affiliated Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiujuan Chen, MD
Organizational Affiliation
Inner Mongolia Medical University affiliated Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Inner Mongolia
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25608991
Citation
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.
Results Reference
background
PubMed Identifier
24343064
Citation
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.
Results Reference
background
PubMed Identifier
21605857
Citation
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.
Results Reference
background
PubMed Identifier
21514582
Citation
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.
Results Reference
background
PubMed Identifier
19515366
Citation
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.
Results Reference
background
PubMed Identifier
18764999
Citation
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.
Results Reference
background
PubMed Identifier
18710719
Citation
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.
Results Reference
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PubMed Identifier
18427974
Citation
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.
Results Reference
background
PubMed Identifier
17387700
Citation
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.
Results Reference
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PubMed Identifier
16978619
Citation
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.
Results Reference
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PubMed Identifier
14680546
Citation
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.
Results Reference
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The Letrozole Administration During Luteal Phase

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