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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)

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

Intervention / Treatment
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* Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)
* Drug: Human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: IVF patients enrolled either to HCG or agonist trigger ovulation induction
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Poor responders. Classical trigger<br>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<br>* Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.<br>* Other names: HCG trigger;|
| Experimental: Poor responders. Agonist trigger<br>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)<br>* Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.<br>* Other names: Agonist trigger;|
| Active Comparator: Normo responders. Classical trigger<br>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<br>* Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.<br>* Other names: HCG trigger;|
| Experimental: Normo responders. Agonist trigger<br>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)<br>* Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.<br>* Other names: Agonist trigger;|
| Active Comparator: High responders. Classical trigger<br>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<br>* Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.<br>* Other names: HCG trigger;|
| Experimental: High responders. Agonist trigger<br>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)<br>* Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.<br>* Other names: Agonist trigger;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mature oocytes | Number of mature oocytes achieved after oocyte retrieval. | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation mature oocytes/punctured oocytes | Relation between the number of mature oocytes and the follicles. | Up to 24 weeks | 
| Fertilized oocytes | Number of fertilized oocytes | Up to 24 weeks | 
| Relation fertilized oocytes/achieved Mature oocytes | Relation between the number of fertilized oocytes and the mature oocytes achieved. | Up to 24 weeks | 
| Number of blastocysts developed | Number of blastocysts developed in each arm of the study. | Up to 24 weeks | 
| Cancelled cycles | Percentage of cancelled cycles | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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agonist trigger, Ovulation induction, Controlled ovarian stimulation (COS), Poor responder