COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS)

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: COOL-COS

Study type: Interventional

Funder types: Other

Identifiers

NCT02288143

CAAE 37537014.6.0000.5440

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

COOL-COS

Experimental group

Description:

All women will receive the intervention: Letrozole, Clomiphene, and low-dose hMG for the controlled ovarian stimulation.

Treatment:

Drug: COOL-COS