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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03307720
Other study ID # AGONIST TRIGGER
Secondary ID
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
Health authority
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

Study Design


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
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