The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

Study Overview
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Brief Summary
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This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.

Detailed Description
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This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.

Official Title
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To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols

Conditions
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Infertility

Intervention / Treatment
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* Drug: Leuprolide acetate
* Drug: vaginal progesterone
* Drug: 4 mg oral estradiol valerate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples undergoing ART with their own gametes. Couples having at least one good embryo available for transfer. Normoresponder Infertility etiology is unexplained ovulation triggered by intramuscular injection of 10000 IU of HCG Exclusion Criteria: Patients older than 38 years old High and poor responder patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LongGnRH agonist protocol(controlgroup)<br>Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate | Drug: vaginal progesterone<br>* crinone gel is applied till fetal heart beat is detected<br>* Other names: crinone gel;Drug: 4 mg oral estradiol valerate<br>* estrofem is given twice a day<br>* Other names: estrofem 2mg tablet;|
| Experimental: Long protocol-leuprolide acetate<br>Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer | Drug: Leuprolide acetate<br>* in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support<br>* Other names: lucrin;Drug: vaginal progesterone<br>* crinone gel is applied till fetal heart beat is detected<br>* Other names: crinone gel;Drug: 4 mg oral estradiol valerate<br>* estrofem is given twice a day<br>* Other names: estrofem 2mg tablet;|
| Active Comparator: GnRHantagonist protocol(control group)<br>GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate | Drug: vaginal progesterone<br>* crinone gel is applied till fetal heart beat is detected<br>* Other names: crinone gel;Drug: 4 mg oral estradiol valerate<br>* estrofem is given twice a day<br>* Other names: estrofem 2mg tablet;|
| Experimental: antagonist protocol-leuprolide acetate<br>GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer | Drug: Leuprolide acetate<br>* in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support<br>* Other names: lucrin;Drug: vaginal progesterone<br>* crinone gel is applied till fetal heart beat is detected<br>* Other names: crinone gel;Drug: 4 mg oral estradiol valerate<br>* estrofem is given twice a day<br>* Other names: estrofem 2mg tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate |  | 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy |  | more than 20 weeks | 
| miscarriage |  | up to 20 weeks | 
| OHSS |  | up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Luteal phase support,GnRH agonist,ART cycles