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Completed

NCT Number: NCT02288143

COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Setor de Reproducao Humana do HC-FMRP-USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COOL-COS

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.
  • hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation.

The triggering will be performed using urinary hCG (5,000 IU subcutaneous).

  • 1-2 days after the identification of one follicle ≥ 17 mm
  • 0-1 days after the identification of one follicle ≥ 19 mm.

Other names: Friendly COS

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 12 days

Secondary outcomes

  1. Number of embryos

    Time frame: 17 days

  2. Ovarian hyper-stimulation syndrome

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study

Acronym: COOL-COS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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