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Double Trigger in Patients With Low Proportion of Mature Oocytes

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Double trigger
HCG trigger
Sponsored by
Riyadh Fertility and Reproductive Health center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring IVF, HCG, GnRH agonist trigger

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Riyadh Fertility and Reproductive Health centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Double trigger

HCG

Arm Description

GnRH-agonist and HCG are used to trigger ovulation

HCG is used to trigger ovulation

Outcomes

Primary Outcome Measures

Number of oocytes retrieved

Secondary Outcome Measures

Clinical pregnancy rate
The presence of gestational sac detected by ultrasound examination

Full Information

First Posted
May 25, 2020
Last Updated
May 28, 2020
Sponsor
Riyadh Fertility and Reproductive Health center
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1. Study Identification

Unique Protocol Identification Number
NCT04407052
Brief Title
Double Trigger in Patients With Low Proportion of Mature Oocytes
Official Title
Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
February 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riyadh Fertility and Reproductive Health center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
IVF, HCG, GnRH agonist trigger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double trigger
Arm Type
Experimental
Arm Description
GnRH-agonist and HCG are used to trigger ovulation
Arm Title
HCG
Arm Type
Active Comparator
Arm Description
HCG is used to trigger ovulation
Intervention Type
Drug
Intervention Name(s)
Double trigger
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
HCG trigger
Intervention Description
Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
First day after oocyte retrieval
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
The presence of gestational sac detected by ultrasound examination
Time Frame
First 5 weeks after oocyte retrieval

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usama M Fouda, Prof.
Phone
+201095401375
Email
umfrfouda@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Organizational Affiliation
Riyadh Fertility and Reproductive Health center
Official's Role
Study Chair
Facility Information:
Facility Name
Riyadh Fertility and Reproductive Health center
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Phone
+201095401375
Email
umfrfouda@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25385007
Citation
Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.
Results Reference
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Double Trigger in Patients With Low Proportion of Mature Oocytes

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