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Search / Trial NCT03142035

Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF

Launched by AMERICAN UNIVERSITY OF BEIRUT MEDICAL CENTER · May 3, 2017

Trial Information

Current as of May 27, 2025

Unknown status

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Primary or secondary infertility
  • Endometriosis, stage III - IV, confirmed surgically by laparoscopy or laparotomy and/or radiologically by the presence of endometrioma on pelvic ultrasound or magnetic resonance imaging (MRI)
  • Normal uterine cavity assessed by hysteroscopy or hysterosalpingogram
  • Normal hormonal profile: TSH, prolactin, fasting blood sugar
  • Normal semen analysis and mild/moderate male factor (Total motile sperm count \> 5 million/ml and/or normal WHO morphology \>20%)
  • First IVF cycle or history of failed IVF cycles
  • Washout period of ≥6 months after any diagnostic or therapeutic surgery for endometriosis or after any medical treatment with Dienogest or GnRH agonist.
  • Exclusion Criteria:
  • • Low ovarian reserve defined by one of the following: low AMH ≤1.5ng/mL and/or basal day 3 FSH ≥ 10mIU/mL and/or basal day 3 Estradiol ≥ 60ng/mL and/or previous egg collection yield of ≤3 oocytes.
  • • Absolute contraindications to dienogest, including:
  • undiagnosed abnormal vaginal bleeding
  • pregnancy and/or lactation
  • active venous thromboembolic disorder
  • history of or current arterial and cardiovascular disease (eg, MI, CVA)
  • diabetes mellitus with vascular involvement
  • history of or current severe hepatic disease where liver function tests remain abnormal
  • history of or current hepatic neoplasia (benign or malignant)
  • known or suspected sex-hormone-dependent malignancy
  • ocular lesions due to ophthalmic vascular disease, such as partial or complete vision loss or defect in visual fields
  • current or history of migraine with focal aura
  • hypersensitivity or poor tolerance to dienogest

About American University Of Beirut Medical Center

The American University of Beirut Medical Center (AUBMC) is a leading academic medical institution in the Middle East, dedicated to advancing healthcare through innovative research, education, and clinical excellence. As a prominent sponsor of clinical trials, AUBMC integrates cutting-edge scientific inquiry with patient-centered care to enhance therapeutic options and improve health outcomes. With a commitment to ethical standards and regulatory compliance, AUBMC collaborates with multidisciplinary teams to conduct rigorous trials that contribute to the global medical knowledge base and address critical health challenges in the region and beyond.

Locations

Beirut, , Lebanon

Patients applied

0 patients applied

Trial Officials

Dina Chamsi, MD

Principal Investigator

American University of Beirut Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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