Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles

May 28, 2020 updated by: Riyadh Fertility and Reproductive Health center

Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles. A Randomized Controlled Trial

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 oocytes yield in patients with history of poor oocytes yield, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Riyadh Fertility and Reproductive Health center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with history of poor oocytes yield in previous IVF attempt, despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of follicles > 14 mm in diameter on day of hCG administration
  • Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt

Exclusion Criteria:

  • Endometriosis
  • PCOS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 co-administration 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: First day after oocyte retrieval
First day after oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: First 5 weeks after oocyte retrieval
The presence of gestational sac detected by ultrasound examination
First 5 weeks after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Fertility and Reproductive Health center

Investigators

  • Study Director: Usama M Fouda, Prof., Riyadh Fertility and Reproductive Health center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

February 2, 2021

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Double trigger/more oocytes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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