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NCT02400801 Clinical Trial

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART in Postoperative Endometriosis Patients

Infertility Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02400801
Other study ID # S55300
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 11, 2015
Last updated June 8, 2017
Start date June 2013
Est. completion date December 2018

Study information
Verified date June 2017
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Does prolonged GnRH downregulation prior to ART improve the clinical pregnancy rate in postoperative endometriosis patients? (A single centre randomised controlled trial)

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 166
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy

- only first three ART cycles

- normal uterine cavity

- Eligible for ovarian stimulation with long agonist protocol

Exclusion Criteria:

- FSH>20 IU/L

- presence of large intramural fibroids (> 3 cm)

- <4 oocytes obtained in any previous fresh ART cycle

- ART with sperm derived from testicular biopsy

- ART with Preimplantation Genetic Diagnosis/Screening

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• triptorelin
gonadotropin-releasing hormone (GnRH) agonist
• ethinylestradiol + dienogest
oral oestroprogestogen

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate per initiated ART cycle participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group
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