Dual Triggering in Patients With a High Immature Oocyte Rate

NCT02813239 | Completed

• 1 other identifier: 1408-MAD-058-JG
• Study Type: observational
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.

Conditions

INFERTILITY

Keywords

IVF; Dual trigger; GnRH agonist; hCG; mature oocytes

Outcome Measures

Primary Outcomes (1)

• Metaphase II rate

  Number of metaphase II among total of recovered oocytes

  1 day

Study Arms (2)

HCG triggering

Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG when at least 2 follicles had a mean diameter of 17 mm.

Other: hCG

HCG + GnRH agonist triggering

Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG and GnRH agonist when at least 2 follicles had a mean diameter of 17 mm.

Other: hCG + GnRH agonist

Interventions

hCG OTHER

Oocyte maturation with hCG

Also known as: OVITRELLE (Merck Serono)

HCG triggering

hCG + GnRH agonist OTHER

Oocyte maturation with hCG + GnRH agonist

Also known as: Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)

HCG + GnRH agonist triggering

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing controlled ovarian stimulation with a high immature oocyte rate

You may qualify if:

• BMI of 18-30 kg/m2
• Male factor required for ICSI

Sponsors & Collaborators

• IVI Madrid: lead

Related Publications (2)

• Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.

  PMID: 25724740 BACKGROUND

• Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.

  PMID: 22749223 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin; Gonadotropin-Releasing Hormone; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins

Study Officials

• Juan Antonio Garcia Velasco, MD

  IVI Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 24, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2015
• Last Updated: June 24, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share