Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

Detailed Description
-----------------
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Official Title
-----------------
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: GnRH agonist
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >21 and < 38 years old polycystic ovarian syndrome risk for ovarian hyperstimulation syndrome Exclusion Criteria: recurrent abortion endometriosis more than 3 IVF failures use of oral contraceptive pills in the preceding 3 months low response to gonadotropins

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 38 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist<br>3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. | Drug: GnRH agonist<br>* 3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation<br>* Other names: Gonal;|
| Active Comparator: Control<br>250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. | Drug: Control<br>* 250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation<br>* Other names: Gonal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of functional rescue of corpus luteum |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 6 months | 
| Levels of serum steroids |  | 6 months | 
| Levels of serum gonadotropins |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corpus luteum rescue, Gonadotropin Releasing Hormone (GnRH agonist), human Chorionic Gonadotropin (hCG), infertility, pregnancy rate