Gametes Transfer vs. Embryo Transfer for Women Undergoing Assisted Reproductive Techniques: a Randomized Controlled Trial
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Sao Paulo
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Ribeirao Preto, Sao Paulo, Brésil, 14049-900
- Setor de Reproducao Humana do HC-FMRP-USP
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intrauterine transfer of gametes
After the oocyte retrieval, the oocytes will be selected depending on the morphology of the granular cells.
The transfer will be conducted in up to 2 hours after the oocytes collection, when the semen and up to 3 oocytes will be transferred.
Surplus oocytes will be cryopreserved for future use.
We will use a Sydney catheter (Cook Medical Inc., Bloomington, IN, USA) coupled to a 1 mL syringe to perform the transfer.
The catheter will be loaded with oocytes and semen prepared in the following sequence: 10 µL of the prepared semen, a small space of air, 20 µL of the medium containing the oocytes, another small space of air and more 10 µL of prepared semen.
The catheter will be placed through the endocervical canal up to the endometrial cavity guided by transabdominal ultrasound, where the liquid will be released.
We will try to place the point of the catheter 1.0-1.5cm
before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds.
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Comparateur actif: intrauterine transfer of embryos
The oocytes will be denuded and those considered to be mature will be selected for fertilization up to the number of seven.
In vitro fertilization will be performed and up to two embryos will be transferred 2-3 days after the oocyte retrieval.
The other embryos will be cryopreserved for future use.
We will use Sidney catheter (Cook Medical Inc.) coupled to a 1 mL syringe to perform the transfer.
The catheter will be loaded with embryos in the following sequence: 10 µL of culture medium, a small space of air, 20 µL of the medium containing embryos, another small space of air, and more 10 µL of culture medium.
The catheter will be placed through the endocervical canal up to the endometrial cavity, guided by transabdominal ultrasound, where the liquid will be released.
We will try to place the point of the catheter 1.0-1.5cm
before touching the fundus of the endometrial cavity and release the liquid slowly, in approximately 30 seconds.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Naissance vivante
Délai: 9 mois
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9 mois
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Nombre d'ovocytes récupérés
Délai: 1 mois
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1 mois
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Clinical pregnancy
Délai: 2 months
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2 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAAE: 03332812.0.0000.5440
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