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

NCT03307720 | Unknown DMC

• 1 other identifier: AGONIST TRIGGER
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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. 1.Poor responders.
2. 2.Normo-responders
3. 3.High responders Comparing both the number and the quality of achieved oocytes.

Conditions

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

Keywords

agonist trigger; Ovulation induction; Controlled ovarian stimulation (COS); Poor responder

Outcome Measures

Primary Outcomes (1)

• Mature oocytes

  Number of mature oocytes achieved after oocyte retrieval.

  Up to 24 weeks

Secondary Outcomes (5)

• Relation mature oocytes/punctured oocytes

  Up to 24 weeks

• Fertilized oocytes

  Up to 24 weeks

• Relation fertilized oocytes/achieved Mature oocytes

  Up to 24 weeks

• Number of blastocysts developed

  Up to 24 weeks

• Cancelled cycles

  Up to 24 weeks

Study Arms (6)

Poor responders. Classical trigger

ACTIVE COMPARATOR

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

Poor responders. Agonist trigger

EXPERIMENTAL

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)

Normo responders. Classical trigger

ACTIVE COMPARATOR

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

Normo responders. Agonist trigger

EXPERIMENTAL

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)

High responders. Classical trigger

ACTIVE COMPARATOR

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

High responders. Agonist trigger

EXPERIMENTAL

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)

Interventions

Gonadotropin Releasing Hormone Agonists (GNRH-A) DRUG

Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.

Also known as: Agonist trigger

High responders. Agonist trigger; Normo responders. Agonist trigger; Poor responders. Agonist trigger

Human chorionic gonadotropin DRUG

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

Also known as: HCG trigger

High responders. Classical trigger; Normo responders. Classical trigger; Poor responders. Classical trigger

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women scheduled for IVF treatment.
• First ovarian stimulation
• Two ovaries present
• No previous ovarian surgery
• No contraindication for any of the assigned treatments

You may not qualify if:

• Previous ovarian surgery.
• Previous IVF treatments.
• Absence of one ovary
• Presence of an endometrioma

Sponsors & Collaborators

• Ginegorama S.L.: lead

Study Sites (1)

Reproduccion Bilbao Assisted Reproduction Center

Bilbao, Bizkaia, 48014, Spain

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Gorka Barrenetxea, PhD

  Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea

  PRINCIPAL INVESTIGATOR

• Jon Iker Arambarri, MD

  Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea

  STUDY CHAIR

Central Study Contacts

Gorka Barrenetxea, PhD

CONTACT

00 34 605711484; gbarrenetxea@reproduccionbilbao.es

Amaia Garcia, PhD

CONTACT

agarcia@reproduccionbilbao.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao

Model Details: IVF patients enrolled either to HCG or agonist trigger ovulation induction

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 12, 2017
• Study Start: December 18, 2017
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)