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

Ginegorama S.L.

Status: Unknown

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

Treatments: Drug: Human chorionic gonadotropin; Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)

Study type: Interventional

Funder types: Other

Identifiers

NCT03307720

AGONIST TRIGGER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 6 patient groups

Poor responders. Classical trigger

Active Comparator group

Description:

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.

Treatment:

Drug: Human chorionic gonadotropin

Poor responders. Agonist trigger

Experimental group

Description:

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.

Treatment:

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)

Normo responders. Classical trigger

Active Comparator group

Description:

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.

Treatment:

Drug: Human chorionic gonadotropin

Normo responders. Agonist trigger

Experimental group

Description:

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.

Treatment:

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)

High responders. Classical trigger

Active Comparator group

Description:

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.

Treatment:

Drug: Human chorionic gonadotropin

High responders. Agonist trigger

Experimental group

Description:

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.

Treatment:

Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)