COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS)
December 1, 2015 updated by: Wellington P Martins, MD, University of Sao Paulo
Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of oocytes retrieved.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo
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Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- Setor de Reproducao Humana do HC-FMRP-USP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women scheduled to controlled ovarian stimulation for oocyte retrieval.
- Body mass index: 18-35 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:
- No exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: COOL-COS
All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation.
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Controlled ovarian stimulation will start on the second or third day of a menstrual cycle:
The triggering will be performed using urinary hCG (5,000 IU subcutaneous).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of oocytes retrieved
Time Frame: 12 days
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12 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of embryos
Time Frame: 17 days
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17 days
|
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Ovarian hyper-stimulation syndrome
Time Frame: 1 month
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
November 6, 2014
First Submitted That Met QC Criteria
November 10, 2014
First Posted (Estimate)
November 11, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 37537014.6.0000.5440
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.