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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01839136
Other study ID # CAAE: 03332812.0.0000.5440
Secondary ID
Status Terminated
Phase N/A
First received April 21, 2013
Last updated June 30, 2014
Start date May 2013

Study information

Verified date June 2014
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Plataforma Brasil: Brazil
Study type Interventional

Clinical Trial Summary

Background: The cost for the treatment of infertility are limiting for the health care access, particularly if we consider that the success rate per cycle is approximately 35%. Alternative regimens for controlled ovarian stimulation (COS)have been described in the medical literature, that lead to a lower cost, fewer injections and less risk of adverse events, particularly ovarian hyperstimulation syndrome. Furthermore, some services report excellent results with less manipulation as possible, which reduces the cost of laboratory of human and ethically be considered less complicated once fertilization occurs in the uterus and not in vitro.

Objectives: The main objective is to compare the reproductive outcomes between intrauterine transfer of gametes (TG) and embryos (TE), the secondary objective is to estimate the average number of eggs that are raised when using an EOC reduced cost.

Methods: This study will be conducted in the area of Human Reproduction, Department of Gynecology and Obstetrics Hospital of the FMRP-USP. We will conduct an open controlled study with random allocation of the participants in a 1:1 ratio, and we plan to include 100 participants. All participants will undergo an EOC reduced cost. We will compare the chance of the treatment (TE or TG) result in a live birth and clinical pregnancy per woman allocated and to estimate the number of oocytes retrieved considering all participants.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Women undergoing ART requiring COS, oocyte retrieval and embryo transfer at the fertility clinic of the university Hospital of the Medical School of Ribeirao Preto, University of Sao Paulo, Brazil.

- Age = 18-40 years

- BMI = 18-30 Kg/m²

- Antral follicle count (AFC) = 5

- Semen concentration and progressive motility above the percentile 2.5 of the fertile men (Cooper et al. 2010): sperm concentration > 9X 106/mL, and progressive motility > 28%.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Intrauterine transfer of gametes

Intrauterine transfer of embryos


Locations

Country Name City State
Brazil Setor de Reproducao Humana do HC-FMRP-USP Ribeirao Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Live birth 9 months No
Secondary Clinical pregnancy 2 months No
Secondary Number of oocytes retrieved 1 month Yes
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