COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

Infertility Clinical Trial

— COOL-COS  

Official title:

Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288143
• Other study ID #: CAAE 37537014.6.0000.5440
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2014
• Last updated: December 1, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	Setor de Reproducao Humana do HC-FMRP-USP	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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 — View 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: 1 — View 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. — View Citation

Nastri CO, Teixeira DM, Moroni RM, Leitão 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved		12 days	Yes
Secondary	Number of embryos		17 days	Yes
Secondary	Ovarian hyper-stimulation syndrome		1 month	Yes