Back to resultsCOmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study (COOL-COS)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
COOL-COS
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Women scheduled to controlled ovarian stimulation for oocyte retrieval.
- Body mass index between 18 and 35 Kg/m2.
- Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L).
- Signing an informed consent.
Exclusion Criteria:
- None
Sites / Locations
- Setor de Reprodução Humana - HC-FMRP-USP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
COOL-COS
Arm Description
All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation
Outcomes
Primary Outcome Measures
Number of oocytes retrieved
Secondary Outcome Measures
Number of embryos
Ovarian hyperstimulation syndrome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02448459
Brief Title
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
Acronym
COOL-COS
Official Title
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the number of oocytes retrieved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COOL-COS
Arm Type
Experimental
Arm Description
All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
COOL-COS
Other Intervention Name(s)
Friendly COS
Intervention Description
Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation.
Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation.
The triggering will be performed using leuprorelin 1 mg (subcutaneous).
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Number of embryos
Time Frame
25 days
Title
Ovarian hyperstimulation syndrome
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women scheduled to controlled ovarian stimulation for oocyte retrieval.
Body mass index between 18 and 35 Kg/m2.
Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L).
Signing an informed consent.
Exclusion Criteria:
None
Facility Information:
Facility Name
Setor de Reprodução Humana - HC-FMRP-USP
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23250342
Citation
Figueiredo JB, Nastri CO, Vieira AD, Martins WP. Clomiphene combined with gonadotropins and GnRH antagonist versus conventional controlled ovarian hyperstimulation without clomiphene in women undergoing assisted reproductive techniques: systematic review and meta-analysis. Arch Gynecol Obstet. 2013 Apr;287(4):779-90. doi: 10.1007/s00404-012-2672-0. Epub 2012 Dec 19.
Results Reference
background
PubMed Identifier
24348019
Citation
Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013. Erratum In: Drug Des Devel Ther. 2017 Apr 28;11:1367.
Results Reference
background
PubMed Identifier
23543584
Citation
Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.
Results Reference
background
PubMed Identifier
24182414
Citation
Seko LM, Moroni RM, Leitao VM, Teixeira DM, Nastri CO, Martins WP. Melatonin supplementation during controlled ovarian stimulation for women undergoing assisted reproductive technology: systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014 Jan;101(1):154-161.e4. doi: 10.1016/j.fertnstert.2013.09.036. Epub 2013 Oct 29.
Results Reference
background
PubMed Identifier
25302750
Citation
Nastri CO, Teixeira DM, Moroni RM, Leitao VM, Martins WP. Ovarian hyperstimulation syndrome: pathophysiology, staging, prediction and prevention. Ultrasound Obstet Gynecol. 2015 Apr;45(4):377-93. doi: 10.1002/uog.14684. Epub 2015 Mar 1.
Results Reference
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COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study
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