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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02448459

Acronym

COOL-COS

Enrollment

Registered

2015-05-19

Start date

2015-05-31

Completion date

2016-05-31

Last updated

2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

DRUGCOOL-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. Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation. The triggering will be performed using leuprorelin 1 mg (subcutaneous).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of oocytes retrieved	20 days

Secondary

Measure	Time frame
Number of embryos	25 days
Ovarian hyperstimulation syndrome	2 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026