Infertility, Endometriosis
Conditions
Keywords
endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality
Brief summary
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
DRUGZoladex
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
Sponsors
Onze Lieve Vrouw Hospital
AZ Jan Palfijn Gent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Metaphase II Cells (MII) | 3 weeks | number of MII cells retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 12 weeks | The number of ongoing pregnancies obtained which still is the most important issue for the patients. |
| Good Embryo Quality | 3 days after oocyte retrieval | 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 Cryopreserved Embryos | 1 week after oocyte retrieval | number of blastocytes that can be cryopreserved |
| Total Follicle Stimulating Hormone (FSH) Dose | 3 weeks | total dose of FSH needed at the end of stimulation |
| Number of Pro Nuclear Cell (2PN) | 1 day after oocyte retrieval | number of 2PN |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Days of Stimulation | 3 weeks | number of days needed before follicles in the ovary are mature for oocyte retrieval |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoladex After 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 | 61 |
| Vaporization Only Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. | 58 |
| Total | 119 |
Baseline characteristics
| Characteristic | Vaporization Only | Zoladex | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 61 Participants | 119 Participants |
| Age, Continuous | 31.70 years STANDARD_DEVIATION 4.28 | 30.33 years STANDARD_DEVIATION 3.63 | 31.02 years STANDARD_DEVIATION 3.96 |
| Region of Enrollment Belgium | 58 participants | 61 participants | 119 participants |
| Sex: Female, Male Female | 58 Participants | 61 Participants | 119 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 61 | 0 / 58 |
| serious Total, serious adverse events | 11 / 61 | 7 / 58 |
Outcome results
Primary
Number of Metaphase II Cells (MII)
number of MII cells retrieved
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoladex | Number of Metaphase II Cells (MII) | 8.2 MII cells | Standard Deviation 5.92 |
| Vaporization Only | Number of Metaphase II Cells (MII) | 8.2 MII cells | Standard Deviation 4.82 |
Secondary
Good Embryo Quality
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.
Time frame: 3 days after oocyte retrieval
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zoladex | Good Embryo Quality | 59.3 percentage of good quality embryos |
| Vaporization Only | Good Embryo Quality | 67.3 percentage of good quality embryos |
Secondary
Number of Cryopreserved Embryos
number of blastocytes that can be cryopreserved
Time frame: 1 week after oocyte retrieval
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoladex | Number of Cryopreserved Embryos | 0.9 number of cryopreserved embryos | Standard Deviation 1.4 |
| Vaporization Only | Number of Cryopreserved Embryos | 1.6 number of cryopreserved embryos | Standard Deviation 2.31 |
Secondary
Number of Pro Nuclear Cell (2PN)
number of 2PN
Time frame: 1 day after oocyte retrieval
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoladex | Number of Pro Nuclear Cell (2PN) | 5.4 number of pro nuclear cells | Standard Deviation 4.03 |
| Vaporization Only | Number of Pro Nuclear Cell (2PN) | 5.6 number of pro nuclear cells | Standard Deviation 4.2 |
Secondary
Pregnancy Rate
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zoladex | Pregnancy Rate | 39.3 percentage of ongoing pregnancies |
| Vaporization Only | Pregnancy Rate | 39.7 percentage of ongoing pregnancies |
Secondary
Total Follicle Stimulating Hormone (FSH) Dose
total dose of FSH needed at the end of stimulation
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoladex | Total Follicle Stimulating Hormone (FSH) Dose | 2561 IUs | Standard Deviation 621.7 |
| Vaporization Only | Total Follicle Stimulating Hormone (FSH) Dose | 2303 IUs | Standard Deviation 604.8 |
Other Pre-specified
Number of Days of Stimulation
number of days needed before follicles in the ovary are mature for oocyte retrieval
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zoladex | Number of Days of Stimulation | 12.3 days | Standard Deviation 1.86 |
| Vaporization Only | Number of Days of Stimulation | 11.3 days | Standard Deviation 1.98 |