Dual Triggering in Patients With a High Immature Oocyte Rate

NCT ID: NCT02813239

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

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.

Detailed Description

Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.

Conditions

INFERTILITY

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

hCG

Intervention Type: OTHER

Oocyte maturation with 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.

hCG + GnRH agonist

Intervention Type: OTHER

Oocyte maturation with hCG + GnRH agonist

Interventions

hCG

Oocyte maturation with hCG

Intervention Type: OTHER

hCG + GnRH agonist

Oocyte maturation with hCG + GnRH agonist

Intervention Type: OTHER

Other Intervention Names

OVITRELLE (Merck Serono); Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Juan A Garcia-Velasco

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Antonio Garcia Velasco, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

References

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.

Reference Type: BACKGROUND

PMID: 25724740 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22749223 (View on PubMed)

Other Identifiers

1408-MAD-058-JG

Identifier Type: -

Identifier Source: org_study_id