COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study

Phase 1

Completed

• Conditions: Infertility
• Interventions: Drug: COOL-COS

• Registration Number: NCT02448459
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2016-03
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COOL-COS	COOL-COS	All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	20 days

Secondary Outcome Measures

Name	Time	Method
Number of embryos	25 days
Ovarian hyperstimulation syndrome	2 months

Trial Locations

Locations (1)

Setor de Reprodução Humana - HC-FMRP-USP; 🇧🇷 Ribeirao Preto, SP, Brazil