Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

Study Description

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Brief Summary:

The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients

Condition or disease	Intervention/treatment	Phase
INFERTILITY; Fertility Preservation; Ovulation Induction; Vitrification; Oocyte Donation	Drug: gonadotropins plus GnRH antagonists; Drug: ganirelix	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	15 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
Study Start Date :	July 2012
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Lutheal phase ovarian stimulation; Early luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage.

Drug: gonadotropins plus GnRH antagonists; Other Name: Ovarian stimulation Drug: ganirelix; Other Name: the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix

Outcome Measures

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Primary Outcome Measures :

1. Pregnancy rate [ Time Frame: six weeks after transfer procedure ]

Secondary Outcome Measures :

1. Number of Mature oocytes [ Time Frame: Day of oocyte retrieval ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• premenopausal women, 18-35 years old, FSH levels < 10 mIU/ml; AFC> 10
• regular cycles
• BMI < 28
• signed informed consent

Recipients:

• Infertile women eligible for oocytes donation
• BMI < 35
• Signed informed consent form

Exclusion Criteria:

-Polycystic ovarian syndrome, gonadotropins allergy

Recipients:

• Women eligible for oocytes donation
• BMI >35
• Uncontrolled Endocrine Pathology

Contacts and Locations

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Locations

Spain
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08037

Sponsors and Collaborators

Institut Universitari Dexeus

FUNDACION DEXEUS SALUT DE LA DONA

Ayudas Merck Serono de Investigación 2012

Investigators

Principal Investigator:	Francisca Martínez, PhD	Fundación Dexeus Salut de la Dona

More Information

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Additional Information:

Related Info 

Publications:

Sönmezer M, Türkçüoğlu I, Coşkun U, Oktay K. Random-start controlled ovarian hyperstimulation for emergency fertility preservation in letrozole cycles. Fertil Steril. 2011 May;95(6):2125.e9-11. doi: 10.1016/j.fertnstert.2011.01.030. Epub 2011 Feb 3.

von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-5. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martínez F, Clua E, Devesa M, Rodríguez I, Arroyo G, González C, Solé M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.

ClinicalTrials.gov Identifier:	NCT01645241 History of Changes
Other Study ID Numbers:	DEX005
First Posted:	July 20, 2012
Last Update Posted:	October 27, 2014
Last Verified:	March 2013

Keywords provided by Institut Universitari Dexeus:

Ovarian stimulation; Luteal phase; Egg donors; Fertility preservation

Additional relevant MeSH terms:

Infertility; Genital Diseases, Male; Genital Diseases, Female; Ganirelix	Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs