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NCT01645241 Clinical Trial

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

INFERTILITY Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01645241
Other study ID # DEX005
Secondary ID
Status Completed
Phase N/A
First received July 18, 2012
Last updated October 24, 2014
Start date July 2012
Est. completion date December 2013

Study information
Verified date March 2013
Source Institut Universitari Dexeus
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gonadotropins plus GnRH antagonists

• ganirelix

Locations
Country Name City State
Spain Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus Barcelona

Sponsors (3)
Lead Sponsor Collaborator
Institut Universitari Dexeus Ayudas Merck Serono de Investigación 2012, FUNDACION DEXEUS SALUT DE LA DONA

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Sönmezer M, Türkçüoglu I, Coskun 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate six weeks after transfer procedure No
Secondary Number of Mature oocytes Day of oocyte retrieval No
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Completed NCT03623659 - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts N/A
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