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Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial

Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01839136
Enrollment
40
Registered
2013-04-24
Start date
2013-05-31
Completion date
Unknown
Last updated
2014-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Assisted Reproductive Techniques, Health Services Accessibility, Ovulation Induction, Embryo Transfer

Brief 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.

Interventions

PROCEDUREIntrauterine transfer of gametes
PROCEDUREIntrauterine transfer of embryos

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

* None

Design outcomes

Primary

MeasureTime frame
Live birth9 months

Secondary

MeasureTime frame
Clinical pregnancy2 months
Number of oocytes retrieved1 month

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026