Trial | NCT01607203  Report issue

Title

Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Study Participants

    120
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
Study Started
Nov 30
2011
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Results Posted
Feb 19
2015
Estimate
Last Update
Feb 19
2015
Estimate

Drug Decapeptyl Daily

Decapeptyl 0.2 mg SC once 1day

  • Other names: Gonapeptyl

Drug pregnyl

5000 IU SC

hCG Active Comparator

5000 IU Pregnyl SC

hCG and GnRH agonist Active Comparator

5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Criteria 

Inclusion Criteria:

Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
1,2 or 3 rd IVF-cycle

Exclusion Criteria:

polycystic ovary syndrome (PCOS) patients
patients with endocrinological diseases or problems

Summary

hCG TRIGGERING

hCG and GnRH Agonist Triggering

All Events

Event Type Organ System Event Term hCG TRIGGERING hCG and GnRH Agonist Triggering

MII Oocytes

the number of mature oocytes retrieved

hCG TRIGGERING

9.2
cumulus oocyte complex (Mean)
Standard Deviation: 6.7

hCG and GnRH Agonist Triggering

10.3
cumulus oocyte complex (Mean)
Standard Deviation: 6.8

Pregnancy Rate

the number of pregnancies obtained, wich still is the most important issue for the patients

hCG Triggering

28.0
pregnancies

hCG and GnRH Agonist Triggering

45.0
pregnancies

Patients With Cryopreserved Embryos

hCG Triggering

21.0
patients with cryopreserved embryos

hCG and GnRH Agonist Triggering

33.0
patients with cryopreserved embryos

Total

120
Participants

Age, Continuous

30.2
YEARS (Mean)
Standard Deviation: 3.8

Body Mass Index

23.7
kg/m^2 (Mean)
Standard Deviation: 4.8

Region of Enrollment

Sex: Female, Male

Overall Study

hCG Triggering

hCG and GnRH Agonist Triggering