IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026193
• Other study ID #: RMB-0439-13
• Status: Completed
• Phase: N/A
• First received: December 30, 2013
• Last updated: May 20, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.

The purpose of this study is to compare the outcome of these two approaches.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• IVF patients

• ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes.

• Normal uterus

Exclusion Criteria:

• <20% fertilization rate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• oocyte vitrification

• embryo freezing

Locations

Country	Name	City	State
Israel	IVF Unit, Rambam medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Heart Activity 1 Month Post Embryo Transfer	Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer	1 month after embryo transfer	No