Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

Study Overview
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Brief Summary
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The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Detailed Description
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Patients will be randomized at the outpatient clinic in two groups.

Official Title
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The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial

Conditions
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Reproductive Endocrinology, Fertility, Optimal Stimulation Protocol

Intervention / Treatment
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* Drug: GnRH agonist
* Drug: GnRH antagonist
* Drug: hP-hMG
* Drug: Human chorionic gonadotropin
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≤ 39 years the day of oocyte retrieval BMI ≤ 29 cycle rank 1 menstrual cycle 25-36 days PGD or preimplantation genetic screening (PGS) requested ICSI Single embryo transfer (SET) on day 5 Exclusion Criteria: Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria) Hormonal disturbances Endometriosis grade III and IV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (GnRH agonist group)<br>The long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels < 80 pg/ml, FSH ≤ 10 IU/l and progesterone < 1,5ng/ml) | Drug: GnRH agonist<br> <br> * Other names: Suprefact nasal spray;Drug: hP-hMG<br> <br> * Other names: Menopur;Drug: Human chorionic gonadotropin<br>* induction of final oocyte maturation<br>* Other names: Pregnyl;Drug: Progesterone<br> <br> * Other names: Utrogestan vaginal tablets;|
| Active Comparator: Group 2 (GnRH antagonist group)<br>Ovarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting. | Drug: GnRH antagonist<br> <br> * Other names: Orgalutran or Cetrotide;Drug: hP-hMG<br> <br> * Other names: Menopur;Drug: Human chorionic gonadotropin<br>* induction of final oocyte maturation<br>* Other names: Pregnyl;Drug: Progesterone<br> <br> * Other names: Utrogestan vaginal tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of day 3 embryos for biopsy available |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature cumulus-oocyte complexes |  | up to 6 weeks | 
| clinical pregnancy rate |  | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracytoplasmic sperm injection (ICSI), PGD, GnrH agonist, GnRH antagonist