Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

Ovarian Reserve Clinical Trial

Official title:

Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789123
• Other study ID #: 2018.11.1.01.082.r1.101
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2018
• Source: Bagcilar Training and Research Hospital
• Contact: Tolga Karacan, M.D
• Phone: 05303638765
• Email: tolgakaracan84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 710
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom

2. Control Group: Patients with reproductive age without any ovarian cysts

Exclusion Criteria:

• suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Reserve

Intervention

Drug:
• Estradiol valerate/dienogest
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.

Locations

Country	Name	City	State
Turkey	Tolga Karacan	Istanbul	Bagcilar

Sponsors (3)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital	Kocaeli Derince Education and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve	The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.	up to 24 months
Secondary	Endometrioma Size	The investigators evaluate endometrioma size (centimeter) using ultrasonography.	up to 24 months
Secondary	Pain Score	Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.	up to 24 months