Oral Contraceptives as Infertility Treatments for Premature Ovarian Failure

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Primary Ovarian Insufficiency, Menopause, Premature

Intervention / Treatment
-----------------
* Drug: Drospirenone and ethinyl estradiol combination (Yasmin)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yasmin<br>Pregnancies will occur while the women are taking oral contraceptives (Yasmin). The possible role of exogenous estrogens in sensitizing the granulosa cells to the effect of follicle-stimulating hormone and thereby inducing ovulation and conception in some women with premature ovarian failure is examined. | Drug: Drospirenone and ethinyl estradiol combination (Yasmin)<br>* Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| multiple pregnancy | The condition of carrying two or more FETUSES. | 3 years | 
| miscarriage | Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. | 3 years |