Primary outcomeMean· 3 weeks
MII Oocytes
| Group | Value (cumulus oocyte complex) | Spread |
|---|---|---|
| hCG TRIGGERING | 9.2 | 6.7 |
| hCG and GnRH Agonist Triggering | 10.3 | 6.8 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataTrial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
NCTNCT01607203 (opens ClinicalTrials.gov in a new tab)Other idDr. Decleer Wim
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 120 participants (actual)
- Sponsor
- AZ Jan Palfijn Gent · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Belgium
- Start
- Nov 2011
- Primary completion
- Dec 2013
- Completion
- Dec 2013
- First posted
- 30 May 2012 (estimated)
- Last update posted
- 19 Feb 2015 (estimated)
- Conditions
- Infertility
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2011201220132014
- Ph 4
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
NCT01607203Nov 2011 to Dec 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Decapeptyl DailyDrug
- pregnylDrug
Arms2
Active comparator
hCG
5000 IU Pregnyl SC
Active comparator
hCG and GnRH agonist
5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
Primary outcomes1
Outcomes the sponsor listed as primary.
MII Oocytes
Time frame · 3 weeks
Registry description
the number of mature oocytes retrieved
Secondary outcomes(2)
Pregnancy Rate
Time frame · 12 weeks
Registry description
the number of pregnancies obtained, wich still is the most important issue for the patients
Patients With Cryopreserved Embryos
Time frame · 4 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeNumber· 12 weeks
Pregnancy Rate
| Group | Value (pregnancies) |
|---|---|
| hCG Triggering | 28 |
| hCG and GnRH Agonist Triggering | 45 |
Secondary outcomeNumber· 4 weeks
Patients With Cryopreserved Embryos
| Group | Value (patients with cryopreserved embryos) |
|---|---|
| hCG Triggering | 21 |
| hCG and GnRH Agonist Triggering | 33 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| hCG TRIGGERINGTRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL | – | 0 / 59 | 0 / 59 |
| hCG and GnRH Agonist TriggeringDUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL | – | 0 / 61 | 0 / 61 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- up to 38 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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