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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48014
      • Reproduccion Bilbao Assisted Reproduction Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ginegorama S.L.
• Investigators: Principal Investigator: Gorka Barrenetxea, PhD, Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea; Study Chair: Jon Iker Arambarri, MD, Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea

Study record dates

Study Major Dates

• Study Start (Anticipated): December 18, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: September 30, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Ovulation induction; agonist trigger; Controlled ovarian stimulation (COS); Poor responder
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormones; Chorionic Gonadotropin
• Other Study ID Numbers: AGONIST TRIGGER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No