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

Not Applicable

• Conditions: In Vitro Fertilization (IVF); Ovulation Induction; Infertility, Female; Oocytes
• Interventions: Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A); Drug: Human chorionic gonadotropin

• Registration Number: NCT03307720
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-11
• Study Start: 2017-12-18
• Primary Completion: 2018-02
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High responders. Agonist trigger	Gonadotropin Releasing Hormone Agonists (GNRH-A)	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.
Poor responders. Agonist trigger	Gonadotropin Releasing Hormone Agonists (GNRH-A)	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.
Normo responders. Agonist trigger	Gonadotropin Releasing Hormone Agonists (GNRH-A)	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.
Poor responders. Classical trigger	Human chorionic gonadotropin	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.
Normo responders. Classical trigger	Human chorionic gonadotropin	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.
High responders. Classical trigger	Human chorionic gonadotropin	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.

Primary Outcome Measures

Name	Time	Method
Mature oocytes	Up to 24 weeks	Number of mature oocytes achieved after oocyte retrieval.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproduccion Bilbao Assisted Reproduction Center; 🇪🇸 Bilbao, Bizkaia, Spain