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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03307720
• Other study ID #: AGONIST TRIGGER
• Status: Not yet recruiting
• Phase: N/A
• First received: September 30, 2017
• Last updated: December 8, 2017
• Start date: December 18, 2017
• Est. completion date: May 2018

Study information

• Verified date: December 2017
• Source: Ginegorama S.L.
• Contact: Gorka Barrenetxea, PhD
• Phone: 00 34 605711484
• Email: gbarrenetxea[@]reproduccionbilbao.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Human chorionic gonadotropin
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.

Locations

Country	Name	City	State
Spain	Reproduccion Bilbao Assisted Reproduction Center	Bilbao	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
Ginegorama S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mature oocytes	Number of mature oocytes achieved after oocyte retrieval.	Up to 24 weeks
Secondary	Relation mature oocytes/punctured oocytes	Relation between the number of mature oocytes and the follicles.	Up to 24 weeks
Secondary	Fertilized oocytes	Number of fertilized oocytes	Up to 24 weeks
Secondary	Relation fertilized oocytes/achieved Mature oocytes	Relation between the number of fertilized oocytes and the mature oocytes achieved.	Up to 24 weeks
Secondary	Number of blastocysts developed	Number of blastocysts developed in each arm of the study.	Up to 24 weeks
Secondary	Cancelled cycles	Percentage of cancelled cycles	Up to 24 weeks