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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COOL-COS

All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation

Group Type EXPERIMENTAL

COOL-COS

Intervention Type DRUG

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).

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.

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

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

Intervention Type DRUG

Other Intervention Names

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Friendly COS

Eligibility Criteria

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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.