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

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ClinicalTrials.gov Identifier: NCT03307720
Recruitment Status : Not yet recruiting
First Posted : October 12, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Gorka Barrenetxea, Ginegorama S.L.

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:

  1. Poor responders.
  2. Normo-responders
  3. High responders Comparing both the number and the quality of achieved oocytes.

Condition or disease Intervention/treatment Phase
Ovulation Induction In Vitro Fertilization (IVF) Infertility, Female Oocytes Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A) Drug: Human chorionic gonadotropin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: IVF patients enrolled either to HCG or agonist trigger ovulation induction
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)
Estimated Study Start Date : December 18, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Poor responders. Classical trigger

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.

Drug: Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
Other Name: HCG trigger

Experimental: Poor responders. Agonist trigger

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.

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)
Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
Other Name: Agonist trigger

Active Comparator: Normo responders. Classical trigger

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.

Drug: Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
Other Name: HCG trigger

Experimental: Normo responders. Agonist trigger

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.

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)
Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
Other Name: Agonist trigger

Active Comparator: High responders. Classical trigger

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.

Drug: Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
Other Name: HCG trigger

Experimental: High responders. Agonist trigger

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.

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)
Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
Other Name: Agonist trigger




Primary Outcome Measures :
  1. Mature oocytes [ Time Frame: Up to 24 weeks ]
    Number of mature oocytes achieved after oocyte retrieval.


Secondary Outcome Measures :
  1. Relation mature oocytes/punctured oocytes [ Time Frame: Up to 24 weeks ]
    Relation between the number of mature oocytes and the follicles.

  2. Fertilized oocytes [ Time Frame: Up to 24 weeks ]
    Number of fertilized oocytes

  3. Relation fertilized oocytes/achieved Mature oocytes [ Time Frame: Up to 24 weeks ]
    Relation between the number of fertilized oocytes and the mature oocytes achieved.

  4. Number of blastocysts developed [ Time Frame: Up to 24 weeks ]
    Number of blastocysts developed in each arm of the study.

  5. Cancelled cycles [ Time Frame: Up to 24 weeks ]
    Percentage of cancelled cycles



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03307720


Contacts
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Contact: Gorka Barrenetxea, PhD 00 34 605711484 gbarrenetxea@reproduccionbilbao.es
Contact: Amaia Garcia, PhD agarcia@reproduccionbilbao.es

Locations
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Spain
Reproduccion Bilbao Assisted Reproduction Center Active, not recruiting
Bilbao, Bizkaia, Spain, 48014
Sponsors and Collaborators
Ginegorama S.L.
Investigators
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Principal Investigator: Gorka Barrenetxea, PhD Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Study Chair: Jon Iker Arambarri, MD Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea

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Responsible Party: Gorka Barrenetxea, Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao, Ginegorama S.L.
ClinicalTrials.gov Identifier: NCT03307720     History of Changes
Other Study ID Numbers: AGONIST TRIGGER
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Gorka Barrenetxea, Ginegorama S.L.:
agonist trigger
Ovulation induction
Controlled ovarian stimulation (COS)
Poor responder

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