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The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes

A

Antalya IVF

Status

Withdrawn

Conditions

Ovarian Hyperstimulation Syndrome
Pregnancy

Treatments

Procedure: final oocyte maturation trigger

Study type

Interventional

Funder types

Other

Identifiers

NCT01979341
App. No. 01042013/103 (Other Identifier)
AntalyaIVF-RCT-dual trigger

Details and patient eligibility

About

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.

In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age; < 40 years
  • Cycle number; cycles 1 or 2
  • Antral follicle count; >10 and <25
  • BMI; >18 and <30
  • Normogonadotrophic cycle length; 24 to 25 days
  • Male; ejaculated semen only

Exclusion criteria

  • Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
  • Previous major uterine surgery (that would affect endometrial receptivity)

Secondary exclusion criteria

  • <5 follicles at the time of trigger
  • <2 full formed blastocyst on day 5 of embryo culture

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 3 patient groups

Dual trigger
Active Comparator group
Description:
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
Treatment:
Procedure: final oocyte maturation trigger
hCG trigger
Active Comparator group
Description:
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)
Treatment:
Procedure: final oocyte maturation trigger
agonist trigger
Active Comparator group
Description:
final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)
Treatment:
Procedure: final oocyte maturation trigger

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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