Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

Primary Ovarian Insufficiency Clinical Trial

Official title:

Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02757469
• Other study ID #: OCPOF-1
• Status: Not yet recruiting
• Phase: N/A
• First received: April 24, 2016
• Last updated: April 27, 2016
• Start date: May 2016
• Est. completion date: May 2021

Study information

• Verified date: April 2016
• Source: Navy General Hospital, Beijing
• Contact: Yunhai Chuai, Dr
• Phone: +86-18810892004
• Email: wangyh85[@]foxmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• premature ovarian failure

• normal anatomy

• normal secondary sexual characteristics

• essential or idiopathic

Exclusion Criteria:

• chromosomal disorder

• iatrogenic injury

• autoimmune diseases

• infection

• genetic diseases

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Infertility
• Menopause, Premature
• Premature Birth
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

Drug:
• Drospirenone and ethinyl estradiol combination (Yasmin)
Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (2)

Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstet Gynecol. 1986 Mar;67(3 Suppl):59S-62S. — View Citation

Ben-Nagi J, Panay N. Premature ovarian insufficiency: how to improve reproductive outcome? Climacteric. 2014 Jun;17(3):242-6. doi: 10.3109/13697137.2013.860115. Epub 2013 Dec 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth	The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).	3 years	Yes
Secondary	clinical pregnancy rate	The ratio of the number of conceptions (CONCEPTION) including LIVE BIRTH; STILLBIRTH; and fetal losses, to the mean number of females of reproductive age in a population during a set time period.	3 years	Yes
Secondary	multiple pregnancy	The condition of carrying two or more FETUSES.	3 years	Yes
Secondary	miscarriage	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.	3 years	Yes