Primary outcomeMean· 3 weeks
Number of Metaphase II Cells (MII)
| Group | Value (MII cells) | Spread |
|---|---|---|
| Zoladex | 8.2 | 5.92 |
| Vaporization Only | 8.2 | 4.82 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataThe Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
NCTNCT01682642 (opens ClinicalTrials.gov in a new tab)Other id2012-000784-25
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
- Mar 2012
- Primary completion
- Oct 2014
- Completion
- Oct 2014
- First posted
- 11 Sept 2012 (estimated)
- Last update posted
- 20 Mar 2015 (estimated)
- Conditions
- Infertility · Endometriosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2012201320142015
- Ph 4
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
NCT01682642Mar 2012 to Oct 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.
Interventions
- ZoladexDrug
Arms2
Active comparator
Zoladex
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
No intervention
vaporization only
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Metaphase II Cells (MII)
Time frame · 3 weeks
Registry description
number of MII cells retrieved
Secondary outcomes(5)
Pregnancy Rate
Time frame · 12 weeks
Registry description
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Good Embryo Quality
Time frame · 3 days after oocyte retrieval
Registry description
The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.
Number of Pro Nuclear Cell (2PN)
Time frame · 1 day after oocyte retrieval
Registry description
number of 2PN
Number of Cryopreserved Embryos
Time frame · 1 week after oocyte retrieval
Registry description
number of blastocytes that can be cryopreserved
Total Follicle Stimulating Hormone (FSH) Dose
Time frame · 3 weeks
Registry description
total dose of FSH needed at the end of stimulation
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(6)
Secondary outcomeNumber· 12 weeks
Pregnancy Rate
| Group | Value (percentage of ongoing pregnancies) |
|---|---|
| Zoladex | 39.3 |
| Vaporization Only | 39.7 |
Secondary outcomeNumber· 3 days after oocyte retrieval
Good Embryo Quality
| Group | Value (percentage of good quality embryos) |
|---|---|
| Zoladex | 59.3 |
| Vaporization Only | 67.3 |
Secondary outcomeMean· 1 day after oocyte retrieval
Number of Pro Nuclear Cell (2PN)
| Group | Value (number of pro nuclear cells) | Spread |
|---|---|---|
| Zoladex | 5.4 | 4.03 |
| Vaporization Only | 5.6 | 4.20 |
Secondary outcomeMean· 1 week after oocyte retrieval
Number of Cryopreserved Embryos
| Group | Value (number of cryopreserved embryos) | Spread |
|---|---|---|
| Zoladex | 0.9 | 1.40 |
| Vaporization Only | 1.6 | 2.31 |
Other pre specified outcomeMean· 3 weeks
Number of Days of Stimulation
| Group | Value (days) | Spread |
|---|---|---|
| Zoladex | 12.3 | 1.86 |
| Vaporization Only | 11.3 | 1.98 |
Secondary outcomeMean· 3 weeks
Total Follicle Stimulating Hormone (FSH) Dose
| Group | Value (IUs) | Spread |
|---|---|---|
| Zoladex | 2561 | 621.7 |
| Vaporization Only | 2303 | 604.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ZoladexAfter surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment | – | 11 / 61 | 1 / 61 |
| Vaporization OnlySurgical vaporization of the endometriosis is done and patients start IVF without additional treatment. | – | 7 / 58 | 0 / 58 |
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
- from 18 Years up to 38 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* laparoscopical vaporization of endometriosis
* 1,2, 3e IVF cycle
* endometriosis stage I and II
* younger than 38 years
Exclusion Criteria:
* endometriosis cysts
* uterine pathology
* endocrinological diseases and problems
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