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

May 19, 2016 updated by: Wellington P Martins, MD, University of Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

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

  • Brazil
    • SP
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Setor de Reprodução Humana - HC-FMRP-USP

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 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 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COOL-COS
All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation
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.

Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation.

The triggering will be performed using leuprorelin 1 mg (subcutaneous).

Other Names:
  • Friendly COS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: 20 days
20 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of embryos
Time Frame: 25 days
25 days
Ovarian hyperstimulation syndrome
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

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

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

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGO482

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.

Clinical Trials on Infertility

Clinical Trials on COOL-COS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe