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Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)

Primary Purpose

Ovulation Induction, In Vitro Fertilization (IVF), Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gonadotropin Releasing Hormone Agonists (GNRH-A)
Human chorionic gonadotropin
Sponsored by
Ginegorama S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovulation Induction focused on measuring agonist trigger, Ovulation induction, Controlled ovarian stimulation (COS), Poor responder

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women scheduled for IVF treatment.
  • First ovarian stimulation
  • Two ovaries present
  • No previous ovarian surgery
  • No contraindication for any of the assigned treatments

Exclusion Criteria:

  • Previous ovarian surgery.
  • Previous IVF treatments.
  • Absence of one ovary
  • Presence of an endometrioma

Sites / Locations

  • Reproduccion Bilbao Assisted Reproduction Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Poor responders. Classical trigger

Poor responders. Agonist trigger

Normo responders. Classical trigger

Normo responders. Agonist trigger

High responders. Classical trigger

High responders. Agonist trigger

Arm Description

Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.

Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.

Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.

Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.

Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.

Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.

Outcomes

Primary Outcome Measures

Mature oocytes
Number of mature oocytes achieved after oocyte retrieval.

Secondary Outcome Measures

Relation mature oocytes/punctured oocytes
Relation between the number of mature oocytes and the follicles.
Fertilized oocytes
Number of fertilized oocytes
Relation fertilized oocytes/achieved Mature oocytes
Relation between the number of fertilized oocytes and the mature oocytes achieved.
Number of blastocysts developed
Number of blastocysts developed in each arm of the study.
Cancelled cycles
Percentage of cancelled cycles

Full Information

First Posted
September 30, 2017
Last Updated
December 8, 2017
Sponsor
Ginegorama S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03307720
Brief Title
Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)
Official Title
Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2017 (Anticipated)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ginegorama S.L.

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
Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS). Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients: Poor responders. Normo-responders High responders Comparing both the number and the quality of achieved oocytes.
Detailed Description
During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS. On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval. Different strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents. Among the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective. So, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovulation Induction, In Vitro Fertilization (IVF), Infertility, Female, Oocytes
Keywords
agonist trigger, Ovulation induction, Controlled ovarian stimulation (COS), Poor responder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
IVF patients enrolled either to HCG or agonist trigger ovulation induction
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Poor responders. Classical trigger
Arm Type
Active Comparator
Arm Description
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
Arm Title
Poor responders. Agonist trigger
Arm Type
Experimental
Arm Description
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
Arm Title
Normo responders. Classical trigger
Arm Type
Active Comparator
Arm Description
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
Arm Title
Normo responders. Agonist trigger
Arm Type
Experimental
Arm Description
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
Arm Title
High responders. Classical trigger
Arm Type
Active Comparator
Arm Description
Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
Arm Title
High responders. Agonist trigger
Arm Type
Experimental
Arm Description
Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
Intervention Type
Drug
Intervention Name(s)
Gonadotropin Releasing Hormone Agonists (GNRH-A)
Other Intervention Name(s)
Agonist trigger
Intervention Description
Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin
Other Intervention Name(s)
HCG trigger
Intervention Description
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
Primary Outcome Measure Information:
Title
Mature oocytes
Description
Number of mature oocytes achieved after oocyte retrieval.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Relation mature oocytes/punctured oocytes
Description
Relation between the number of mature oocytes and the follicles.
Time Frame
Up to 24 weeks
Title
Fertilized oocytes
Description
Number of fertilized oocytes
Time Frame
Up to 24 weeks
Title
Relation fertilized oocytes/achieved Mature oocytes
Description
Relation between the number of fertilized oocytes and the mature oocytes achieved.
Time Frame
Up to 24 weeks
Title
Number of blastocysts developed
Description
Number of blastocysts developed in each arm of the study.
Time Frame
Up to 24 weeks
Title
Cancelled cycles
Description
Percentage of cancelled cycles
Time Frame
Up to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women scheduled for IVF treatment. First ovarian stimulation Two ovaries present No previous ovarian surgery No contraindication for any of the assigned treatments Exclusion Criteria: Previous ovarian surgery. Previous IVF treatments. Absence of one ovary Presence of an endometrioma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gorka Barrenetxea, PhD
Phone
00 34 605711484
Email
gbarrenetxea@reproduccionbilbao.es
First Name & Middle Initial & Last Name or Official Title & Degree
Amaia Garcia, PhD
Email
agarcia@reproduccionbilbao.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gorka Barrenetxea, PhD
Organizational Affiliation
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon Iker Arambarri, MD
Organizational Affiliation
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Official's Role
Study Chair
Facility Information:
Facility Name
Reproduccion Bilbao Assisted Reproduction Center
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)

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