COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation
NCT ID: NCT02288143
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
2015-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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COOL-COS
All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation.
COOL-COS
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.
* hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation.
The triggering will be performed using urinary hCG (5,000 IU subcutaneous).
* 1-2 days after the identification of one follicle ≥ 17 mm
* 0-1 days after the identification of one follicle ≥ 19 mm.
Interventions
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COOL-COS
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.
* hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation.
The triggering will be performed using urinary hCG (5,000 IU subcutaneous).
* 1-2 days after the identification of one follicle ≥ 17 mm
* 0-1 days after the identification of one follicle ≥ 19 mm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Wellington P Martins, MD
Associate Professor
Locations
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Setor de Reproducao Humana do HC-FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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.
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.
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;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.
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.
Other Identifiers
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CAAE 37537014.6.0000.5440
Identifier Type: -
Identifier Source: org_study_id