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Extending the hCG OPU Interval (DelOPU)

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ClinicalTrials.gov Identifier: NCT02871154
Recruitment Status : Unknown
Verified August 2016 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
The Baruch Padeh Medical Center, Poriya

Brief Summary:

Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit.

We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.


Condition or disease Intervention/treatment Phase
Infertility Other: Delaying oocyte pick up beyond 39 hours post hCG Not Applicable

Detailed Description:
In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extending the Time Period Between the Injection of Chorionic Gonadotropin and Oocyte Pick-up as a Solution to Low Rate of Mature Oocyte and Poor Results in Assisted Reproduction
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Delay
Delaying oocyte pick up beyond 39 hours post hCG
Other: Delaying oocyte pick up beyond 39 hours post hCG
Unlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours




Primary Outcome Measures :
  1. Conception [ Time Frame: Two years ]


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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Previous 2 oocyte pick up cycles with 20% metaphase II oocytes in the cohort -

Exclusion Criteria:

No previous IVF history


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871154


Contacts
Contact: Izhar Ben Shlomo, MD 972-52-6124781 ibenshlomo@poria.health.gov.il
Contact: Johenny S Younis, MD 972-50-6265477 jyounis@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Study Director: Odeh-L'ya Katz, PhD Beruch Padeh Med Ctr Research Authority

Responsible Party: The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT02871154     History of Changes
Other Study ID Numbers: 0041-16-POR
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs