Clinical trial NCT03307720: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ovulation Induction
In Vitro Fertilization (IVF)
Infertility, Female
Oocytes
Keywords: agonist trigger
Ovulation induction
Controlled ovarian stimulation (COS)
Poor responder
Lead sponsor: Ginegorama S.L.
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IVF patients enrolled either to HCG or agonist trigger ovulation induction
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Mature oocytes
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Relation mature oocytes/punctured oocytes
timeFrame: Up to 24 weeks
measure: Fertilized oocytes
timeFrame: Up to 24 weeks
measure: Relation fertilized oocytes/achieved Mature oocytes
timeFrame: Up to 24 weeks
measure: Number of blastocysts developed
timeFrame: Up to 24 weeks
measure: Cancelled cycles
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Reproduccion Bilbao Assisted Reproduction Center
state: Bizkaia
Study officials:
affiliation: Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
name: Gorka Barrenetxea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
name: Jon Iker Arambarri, MD
role: STUDY_CHAIR
References: