Phase 4
N=120
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
Infertility · Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT01682642 ↗Enrolled (actual)
120
Serious AEs
15.1%
Results posted
Mar 2015
Primary outcome: Primary: Number of Metaphase II Cells (MII) — 8.2; 8.2 MII cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zoladex (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AZ Jan Palfijn Gent
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Metaphase II Cells (MII) |
8.2; 8.2 | — |
| SECONDARY Pregnancy Rate |
39.3; 39.7 | — |
| SECONDARY Good Embryo Quality |
59.3; 67.3 | — |
| SECONDARY Number of Pro Nuclear Cell (2PN) |
5.4; 5.6 | — |
| SECONDARY Number of Cryopreserved Embryos |
0.9; 1.6 | — |
| SECONDARY Total Follicle Stimulating Hormone (FSH) Dose |
2561; 2303 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01682642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.