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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Infertility; Endometriosis

Treatments: Drug: triptorelin; Drug: ethinylestradiol + dienogest

Study type: Interventional

Funder types: Other

Identifiers

NCT02400801

S55300

Details and patient eligibility

About

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

Enrollment: 166 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

oral oestroprogestogen pre-treatment

Active Comparator group

Description:

preparation with oral oestroprogestogens prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Treatment:

Drug: ethinylestradiol + dienogest

gonadotropin-releasing hormone (GnRH) pre-treatment

Experimental group

Description:

preparation with gonadotropin-releasing hormone (GnRH) analogues prior to downregulation in an assisted reproductive technology treatment (ART) cycle

Treatment:

Drug: triptorelin