Clinical Research Details

Descriptive Information
Dienogest versus Gonadotropin releasing hormone agonist pre-treatment in women with endometriosis undergoing in Vitro Fertilization

Dina Chamsy


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

Conditions and Keywords
Study Design
Safety and/or Efficacy Study
N/A: Not Applicable
Eligibility and IRB
Min: 18
Max: 38

We will conduct a non-blinded randomized controlled trial on women presenting to AUBMC for IVF/ICSI due to stage 3 or 4 endometriosis.

One group will receive dienogest 2mg daily for a period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle.

The second group will receive one injection of 3.75mg of GnRH-a every month for three doses, followed by a standard IVF/ICSI cycle 3 months later.

The third group will not receive any medical interventions before the planned IVF/ICSI cycle.

We hypothesize that patients receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving the GnRH-a injection. 

The subject population consists of women known to have infertility and advanced stage endometriosis, who are seeking IVF in the private clinics or outpatient clinics at the Obstetrics and Gynecology Department.

random sampling

Inclusion criteria:

·      Age > 18 years at the time of enrollment

·      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

·      First IVF cycle or history of failed IVF cycles

·      Washout period of ≥2 months after any diagnostic or therapeutic surgery for endometriosis or after any medical treatment with Dienogest or GnRH agonist.



Exclusion criteria

·      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