Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)
NCT ID: NCT03307720
Last Updated: 2017-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2017-12-18
2018-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
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.
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.
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.
Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
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.
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.
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.
Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
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.
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.
Interventions
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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.
Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First ovarian stimulation
* Two ovaries present
* No previous ovarian surgery
* No contraindication for any of the assigned treatments
Exclusion Criteria
* Previous IVF treatments.
* Absence of one ovary
* Presence of an endometrioma
18 Years
48 Years
FEMALE
No
Sponsors
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Ginegorama S.L.
OTHER
Responsible Party
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Gorka Barrenetxea
Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao
Principal Investigators
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Gorka Barrenetxea, PhD
Role: PRINCIPAL_INVESTIGATOR
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Jon Iker Arambarri, MD
Role: STUDY_CHAIR
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Locations
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Reproduccion Bilbao Assisted Reproduction Center
Bilbao, Bizkaia, Spain
Countries
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Central Contacts
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Other Identifiers
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AGONIST TRIGGER
Identifier Type: -
Identifier Source: org_study_id