Transfer Strategy in an Oocyte Donation Programme

Infertility, Female Clinical Trial

Official title:

Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03088735
• Other study ID #: SMD-2017-03
• Status: Terminated
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2021
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.

Exclusion Criteria:

• Preimplantation genetic screening or diagnosis cycles.

• Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.

Related Conditions & MeSH terms

• Embryo Transfer
• Infertility
• Infertility, Female
• Oocyte Donation

Intervention

Procedure:
• Blastocyst-stage embryo transfer strategy
Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.
• Cleavage-stage embryo transfer strategy
Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients

Locations

Country	Name	City	State
Spain	Department Obstetric, Gynecologic and Reproductive Medicine	Barcelona	Barcelons

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative live birth rate	Total number of births considering fresh and frozen thawed embryos transferred	at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Secondary	Cumulative pregnancy rate	Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.	at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle

External Links

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