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Double Trigger in Patients With Low Proportion of Mature Oocytes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407052
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Riyadh Fertility and Reproductive Health center

Brief Summary:
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Double trigger Drug: HCG trigger Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial
Estimated Study Start Date : May 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double trigger
GnRH-agonist and HCG are used to trigger ovulation
Drug: Double trigger
Final follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively

Active Comparator: HCG
HCG is used to trigger ovulation
Drug: HCG trigger
Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval




Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: First day after oocyte retrieval ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: First 5 weeks after oocyte retrieval ]
    The presence of gestational sac detected by ultrasound examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG).
  • Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

  • Endometriosis
  • PCOS

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): NCT04407052


Contacts
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Contact: Usama M Fouda, Prof. +201095401375 umfrfouda@yahoo.com

Locations
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Egypt
Riyadh Fertility and Reproductive Health center Recruiting
Giza, Egypt
Contact: Usama M Fouda, Prof.    +201095401375    umfrfouda@yahoo.com   
Sponsors and Collaborators
Riyadh Fertility and Reproductive Health center
Investigators
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Study Chair: Usama M Fouda, Prof. Riyadh Fertility and Reproductive Health center
Publications:
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Responsible Party: Riyadh Fertility and Reproductive Health center
ClinicalTrials.gov Identifier: NCT04407052    
Other Study ID Numbers: Double trigger/mature oocytes
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riyadh Fertility and Reproductive Health center:
IVF
HCG
GnRH agonist trigger
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female