Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve

Study Overview
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Brief Summary
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Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).

Official Title
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Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues

Conditions
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Infertility

Intervention / Treatment
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* Drug: Clomifene Citrate
* Drug: GnRH analog and recombinant human FSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-42 years infertility status Day 3 serum FSH > 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation Exclusion Criteria: contraindications to infertility treatments or pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High doses<br>Administration of high doses of gonadotrophins to stimulate ovarian follicular growth | Drug: GnRH analog and recombinant human FSH<br>* daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.<br>* Other names: Gonal-F;|
| Experimental: Clomid<br>Administration of Clomiphene Citrate to obtain ovarian follicular growth | Drug: Clomifene Citrate<br>* 3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle<br>* Other names: clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | general Live birth rate will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment. Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy. | end of the study (28 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio pregnancies/costs | at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups. | end of the study (28 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian reserve, ovarian stimulation, clomifene citrate, high doses Follicle Stimulating Hormone (FSH)